V. Mueller
V. Mueller THORACOSCOPIC METZENBAUM SCIS 3.5CM BL, withBLUNT TIP, 10MM SH WORKING LENGTH 7.75 inches 19.5CM OVERALL LENGTH 11.5 inches 29CM
65manufacturers in China registered for this device type
661catalogue numbers in this listing
2510(k) clearances naming this product code
1recall
Who Else Makes It
Concentrated in Guangdong (24), Zhejiang (13), Shanghai (10). 23 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Medical Technologies (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 77 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Hangzhou Kangji Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 27 |
| Modern Medical Equipment Manufacturing Ltd. | Heng Li, Dongguan | Guangdong | Contract manufacturer | 26 |
| Amphenol Alden Products Company | Shenzhen | Guangdong | Contract manufacturer | 24 |
| Hangzhou Endo Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 19 |
| Hong Qiangxing (Shen Zhen) Electronics Limited | Shenzhen | Guangdong | Contract manufacturer | 19 |
| Shenzhen MED-Link Electronics Tech Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 18 |
| Sanbor Medical Xiamen, Inc. | Xiamen | Fujian | Contract manufacturer | 16 |
| ATL Technology DG,Ltd. | Dongguan | Guangdong | Contract manufacturer | 14 |
| Jiangyin Sinbon Electronics Co Ltd | Jiangyin | Jiangsu | Contract manufacturer | 13 |
| Guangzhou Huada Biotechnology Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 9 |
Showing 12 of 65. All 65 manufacturers in China registered for Electrosurgical, Cutting & Coagulation & Accessories
Record
| Listed by | Steris Corporation, United States |
|---|---|
| FDA product code | GEI |
| Device type | Electrosurgical, Cutting & Coagulation & Accessories |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4400 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K811820 |
| Record published | 2017-10-20 |
| Record revised | 2025-11-24 (version 9) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Over the counter | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Box of 10, box of 5, case of 10 |
| Distribution end date | 2024-11-06 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| LAT-0545-CM | In distribution | |
| F-1335 | In distribution | |
| RH6807 | In distribution | |
| LAT-0536-NHCL | In distribution | |
| LAT-1036-MD | In distribution | |
| LA8229 | In distribution | |
| CH2455-1 | In distribution | |
| LA8415 | In distribution | |
| EBP11060-24S | In distribution | |
| EBP11060-14A | In distribution | |
| LAT-0545-DGC | In distribution | |
| EBP15150-11A | In distribution | |
| NL3785-097 | In distribution | |
| NL1551 | In distribution | |
| EBP18150-12S | In distribution | |
| LAT-0545-SM | In distribution | |
| LA8252-45 | In distribution | |
| NL1552 | In distribution | |
| NL3785-112 | In distribution | |
| LAT-0333-NN | In distribution | |
| EBP18200-22S | In distribution | |
| LAT-0545-MX90 | In distribution | |
| CH2467 | In distribution | |
| LA8513 | In distribution | |
| LAT-0321-HS | In distribution | |
| LA8507 | In distribution | |
| EBP11100-24S | In distribution | |
| EBP07045-53A | In distribution | |
| EBP22030-22S | In distribution | |
| EBP22100-12S | In distribution | |
| EBP18050-42S | In distribution | |
| LAT-0545-HS | In distribution | |
| EBP22150-22D | In distribution | |
| EBP18100-31S | In distribution | |
| LA8225 | In distribution | |
| LAT-0333-CM | In distribution | |
| EBP07025-53A | In distribution | |
| EBP18200-11A | In distribution | |
| LAT-H-R | In distribution | |
| NL1553 | In distribution | |
| EBP12100-15S | In distribution | |
| EBP24200-12U | In distribution | |
| CH2465-1 | In distribution | |
| LAT-H-NR | In distribution | |
| EBP20030-21S | In distribution | |
| NL3785-081 | In distribution | |
| CH5915 | In distribution | |
| LAT-0545-DF | In distribution | |
| LA8204P | In distribution | |
| EBP20100-21A | In distribution | |
| LAT-0545-WSA | In distribution | |
| EBP22100-11A | In distribution | |
| EBP23BNT-17C | In distribution | |
| LA8302 | In distribution | |
| EBP22200-41S | In distribution | |
| EBP22150-12D | In distribution | |
| EBP3CRD-UNV | In distribution | |
| EBP18100-12S | In distribution | |
| EBP24030-12S | In distribution | |
| EBP18BNT-17C | In distribution | |
| LA8223 | In distribution | |
| EBP18150-32S | In distribution | |
| F-1112 | In distribution | |
| LA8207 | In distribution | |
| LA8705 | In distribution | |
| EBP15030-21A | In distribution | |
| EBP20100-22S | In distribution | |
| LAT-0536-MSS | In distribution | |
| EBP24100-11S | In distribution | |
| LAT-0545-AG | In distribution | |
| F-2004 | In distribution | |
| CH2465 | In distribution | |
| NL3785-119 | In distribution | |
| LA8201 | In distribution | |
| LA8224 | In distribution | |
| EBP18100-11S | In distribution | |
| EBP18100-12U | In distribution | |
| LAT-0545-DB | In distribution | |
| EBP20060-22S | In distribution | |
| LA6466 | In distribution | |
| LA8410 | In distribution | |
| EBP11060-54C | In distribution | |
| LAT-0536-BCT | In distribution | |
| F-5303 | In distribution | |
| EBP15030-11S | In distribution | |
| NL3785-095 | In distribution | |
| LA-0533-NHCR | In distribution | |
| EBP22200-22S | In distribution | |
| LAT-0545-MD | In distribution | |
| EBP18100-11A | In distribution | |
| LAT-0545-SG | In distribution | |
| EBP20030-12U | In distribution | |
| LAT-0545-NN | In distribution | |
| EBP20030-12D | In distribution | |
| LA8232 | In distribution | |
| EBP11060-54A | In distribution | |
| LAT-0333-BCT | In distribution | |
| LA8228-45 | In distribution | |
| EBP24030-11S | In distribution | |
| EBP22150-42S | In distribution | |
| OP34860 | In distribution | |
| F-5128 | In distribution | |
| EBP22100-12D | In distribution | |
| NL1808 | In distribution | |
| LA8210 | In distribution | |
| K14-3000 | In distribution | |
| EBP18100-21S | In distribution | |
| EBP24150-12D | In distribution | |
| LA8515 | In distribution | |
| EBP18030-12U | In distribution | |
| EBP15150-21A | In distribution | |
| EBP24100-12S | In distribution | |
| LA8307 | In distribution | |
| LA8810-30 | In distribution | |
| LAT-0333-CSA | In distribution | |
| LAT-0545-BG | In distribution | |
| LA6462 | In distribution | |
| CH2450 | In distribution | |
| EBP20100-11A | In distribution | |
| LA8706 | In distribution | |
| CH9323-2 | In distribution | |
| EBP24150-11S | In distribution | |
| EBP22050-42S | In distribution | |
| CH5916-2 | In distribution | |
| EBP24030-12U | In distribution | |
| NL1554 | In distribution | |
| EBP11060-14S | In distribution | |
| LA8108 | In distribution | |
| LAT-0536-MSC | In distribution | |
| F-1304 | In distribution | |
| EBP20050-42S | In distribution | |
| LA8271 | In distribution | |
| LAT-0536-WDA | In distribution | |
| LA8509-45 | In distribution | |
| LAT-0536-CL | In distribution | |
| LA8280 | In distribution | |
| F-5127 | In distribution | |
| NL1870-005 | In distribution | |
| CH2029 | In distribution | |
| EBP22100-22S | In distribution | |
| LAT-0545-WDA | In distribution | |
| CH2453-3 | In distribution | |
| EBP24200-22S | In distribution | |
| LA8106 | In distribution | |
| OP0914-201 | In distribution | |
| EBP22100-32S | In distribution | |
| EBP22150-12U | In distribution | |
| LA8230 | In distribution | |
| EBP20150-12U | In distribution | |
| LAT-0545-UG | In distribution | |
| EBP20100-42S | In distribution | |
| EBP22050-41S | In distribution | |
| LAT-0545-NHCL | In distribution | |
| F-1110 | In distribution | |
| F-1303 | In distribution | |
| LA6476 | In distribution | |
| LA6229 | In distribution | |
| EBP11025-54A | In distribution | |
| EBP11025-54C | In distribution | |
| LAT-0536-AT | In distribution | |
| F-5125 | In distribution | |
| EBP28BNT-16C | In distribution | |
| EBP15030-11A | In distribution | |
| F-1113 | In distribution | |
| NL3785-104 | In distribution | |
| LAT-0536-KLY | In distribution | |
| LAT-0536-NHP | In distribution | |
| EBP11025-24S | In distribution | |
| LA8243 | In distribution | |
| EBP11025-54S | In distribution | |
| F-5014 | In distribution | |
| EBP22050-32S | In distribution | |
| LAT-0545-TN | In distribution | |
| OP0914-001 | In distribution | |
| NL1802 | In distribution | |
| EBP20100-21S | In distribution | |
| NL1807 | In distribution | |
| LA8510-45 | In distribution | |
| LA6558 | In distribution | |
| EBP20150-11S | In distribution | |
| LA8505-45 | In distribution | |
| F-5061 | In distribution | |
| EBP24150-11A | In distribution | |
| F-1030 | In distribution | |
| EBP24150-12S | In distribution | |
| EBP22200-12S | In distribution | |
| EBP11025-14C | In distribution | |
| LAT-0333-HS | In distribution | |
| LA8526 | In distribution | |
| EBP24100-11A | In distribution | |
| NL3785-113 | In distribution | |
| OP0914-301 | In distribution | |
| EBP20200-22S | In distribution | |
| LA8212 | In distribution | |
| EBP20200-41S | In distribution | |
| EBP15150-11S | In distribution | |
| F-3010 | In distribution | |
| LA8103-45 | In distribution | |
| LA6471 | In distribution | |
| LAT-0545 | In distribution | |
| EBP22030-12D | In distribution | |
| LA8106-45 | In distribution | |
| LA8220 | In distribution | |
| CH2455 | In distribution | |
| EBP18100-42S | In distribution | |
| F-1111 | In distribution | |
| NL3785-102 | In distribution | |
| EBP3CRD-VLB | In distribution | |
| CH5916-3 | In distribution | |
| EBP18150-21A | In distribution | |
| F-5022 | In distribution | |
| LA8239-45 | In distribution | |
| LA8281 | In distribution | |
| LAT-0321-BCT | In distribution | |
| LA8307-45 | In distribution | |
| LAT-0536-CW | In distribution | |
| LA8282 | In distribution | |
| EBP22100-42S | In distribution | |
| EBP18150-21S | In distribution | |
| EBP20200-12U | In distribution | |
| LA8515-45 | In distribution | |
| A230.50S | In distribution | |
| EBP20150-32S | In distribution | |
| LA8506 | In distribution | |
| LA8234-45 | In distribution | |
| CH2453-2 | In distribution | |
| LA8505 | In distribution | |
| LA8220P | In distribution | |
| EBP20200-21S | In distribution | |
| LA8411 | In distribution | |
| EBP22100-22U | In distribution | |
| LA8278 | In distribution | |
| EBP20200-11A | In distribution | |
| F-1301 | In distribution | |
| LAT-0321-MD | In distribution | |
| LA8226 | In distribution | |
| LA8202 | In distribution | |
| LA8517-45 | In distribution | |
| F-1003 | In distribution | |
| LAT-1036-CSA | In distribution | |
| LAT-0545-NHP | In distribution | |
| NL3785-121 | In distribution | |
| EBP22100-12U | In distribution | |
| LA8242 | In distribution | |
| LA8303 | In distribution | |
| EBP20150-22S | In distribution | |
| NL3785-080 | In distribution | |
| LA8217 | In distribution | |
| LA8810-0 | In distribution | |
| EBP20100-11S | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Surgical Direct | Surgical Direct, Inc. | 5,729 |
| Speedlock | National Advanced Endoscopy Devices, Inc. | 5,212 |
| Stingray Surgical Products | Stingray Surgical Products L.L.C. | 4,647 |
| Kirwan | Kirwan Surgical Products, LLC. | 1,901 |
| Millennium | Avalign Technologies, Inc. | 1,779 |
| DANmed | Dannoritzer Medizintechnik GmbH & Co. KG | 1,590 |
| Elmed | Elmed, Inc. | 1,519 |
| Symmetry Olsen | Aspen Surgical Products, Inc. | 1,219 |
| Guenter Bissinger Medizintechnik GmbH | Günter Bissinger Medizintechnik GmbH | 1,117 |
| Ambler Surgical | Ambler Surgical, LLC | 756 |
| Aesculap | Aesculap AG | 544 |
| Novo Surgical | Novo Surgical, Inc. | 510 |
Showing 12 of 2,922. All products under Electrosurgical, Cutting & Coagulation & Accessories
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K242773 | 2025-04-15 |
| K241055 | 2024-05-31 |
Recalls Naming This Product
45 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Carefusion 2200, Inc. | UDI-DI | 2022-11-02 | Class II | Under Investigation by firm | BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer’s IFU. This missing content is related to the interface with the device power supply, as well as cleaning | 1369 units |
| Carefusion 2200, Inc. | UDI-DI | 2022-11-02 | Class II | Under Investigation by firm | BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer’s IFU. This missing content is related to the interface with the device power supply, as well as cleaning | 418 units |
| Carefusion 2200, Inc. | UDI-DI | 2022-11-02 | Class II | Under Investigation by firm | BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer’s IFU. This missing content is related to the interface with the device power supply, as well as cleaning | 347 units |
| Carefusion 2200, Inc. | UDI-DI | 2022-11-02 | Class II | Under Investigation by firm | BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer’s IFU. This missing content is related to the interface with the device power supply, as well as cleaning | 218 units |
| Carefusion 2200, Inc. | UDI-DI | 2022-11-02 | Class II | Under Investigation by firm | BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer’s IFU. This missing content is related to the interface with the device power supply, as well as cleaning | 84 units |
| Carefusion 2200, Inc. | UDI-DI | 2022-11-02 | Class II | Under Investigation by firm | BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer’s IFU. This missing content is related to the interface with the device power supply, as well as cleaning | 203 units |
| Carefusion 2200, Inc. | UDI-DI | 2022-11-02 | Class II | Under Investigation by firm | BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer’s IFU. This missing content is related to the interface with the device power supply, as well as cleaning | 119 units |
| Carefusion 2200, Inc. | UDI-DI | 2022-11-02 | Class II | Under Investigation by firm | BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer’s IFU. This missing content is related to the interface with the device power supply, as well as cleaning | 25 units |
| Carefusion 2200, Inc. | UDI-DI | 2022-11-02 | Class II | Under Investigation by firm | BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer’s IFU. This missing content is related to the interface with the device power supply, as well as cleaning | 57 units |
| Carefusion 2200, Inc. | UDI-DI | 2022-11-02 | Class II | Under Investigation by firm | BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer’s IFU. This missing content is related to the interface with the device power supply, as well as cleaning | 100 units |
| Carefusion 2200, Inc. | UDI-DI | 2022-11-02 | Class II | Under Investigation by firm | BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer’s IFU. This missing content is related to the interface with the device power supply, as well as cleaning | 259 units |
| Carefusion 2200, Inc. | UDI-DI | 2022-11-02 | Class II | Under Investigation by firm | BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer’s IFU. This missing content is related to the interface with the device power supply, as well as cleaning | 146 units |
| Carefusion 2200, Inc. | UDI-DI | 2022-11-02 | Class II | Under Investigation by firm | BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer’s IFU. This missing content is related to the interface with the device power supply, as well as cleaning | 9 units |
| Carefusion 2200, Inc. | UDI-DI | 2022-11-02 | Class II | Under Investigation by firm | BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer’s IFU. This missing content is related to the interface with the device power supply, as well as cleaning | 52 units |
| Carefusion 2200, Inc. | UDI-DI | 2022-11-02 | Class II | Under Investigation by firm | BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer’s IFU. This missing content is related to the interface with the device power supply, as well as cleaning | 17 units |
| Carefusion 2200, Inc. | UDI-DI | 2022-11-02 | Class II | Under Investigation by firm | BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer’s IFU. This missing content is related to the interface with the device power supply, as well as cleaning | 132 units |
| Carefusion 2200, Inc. | UDI-DI | 2022-11-02 | Class II | Under Investigation by firm | BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer’s IFU. This missing content is related to the interface with the device power supply, as well as cleaning | 41 units |
| Carefusion 2200, Inc. | UDI-DI | 2022-11-02 | Class II | Under Investigation by firm | BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer’s IFU. This missing content is related to the interface with the device power supply, as well as cleaning | 128 units |
| Carefusion 2200, Inc. | UDI-DI | 2022-11-02 | Class II | Under Investigation by firm | BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer’s IFU. This missing content is related to the interface with the device power supply, as well as cleaning | 1810 units |
| Carefusion 2200, Inc. | UDI-DI | 2022-11-02 | Class II | Under Investigation by firm | BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer’s IFU. This missing content is related to the interface with the device power supply, as well as cleaning | 236 units |
| Carefusion 2200, Inc. | UDI-DI | 2022-11-02 | Class II | Under Investigation by firm | BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer’s IFU. This missing content is related to the interface with the device power supply, as well as cleaning | 27 units |
| Carefusion 2200, Inc. | UDI-DI | 2022-11-02 | Class II | Under Investigation by firm | BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer’s IFU. This missing content is related to the interface with the device power supply, as well as cleaning | 1063 units |
| Carefusion 2200, Inc. | UDI-DI | 2022-11-02 | Class II | Under Investigation by firm | BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer’s IFU. This missing content is related to the interface with the device power supply, as well as cleaning | 4557 units |
| Carefusion 2200, Inc. | UDI-DI | 2022-11-02 | Class II | Under Investigation by firm | BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer’s IFU. This missing content is related to the interface with the device power supply, as well as cleaning | 15 units |
| Carefusion 2200, Inc. | UDI-DI | 2022-11-02 | Class II | Under Investigation by firm | BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer’s IFU. This missing content is related to the interface with the device power supply, as well as cleaning | 2 unist |
| Carefusion 2200, Inc. | UDI-DI | 2022-11-02 | Class II | Under Investigation by firm | XXX | 4 units |
| Carefusion 2200, Inc. | UDI-DI | 2022-11-02 | Class II | Under Investigation by firm | BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer’s IFU. This missing content is related to the interface with the device power supply, as well as cleaning | 11 units |
| Carefusion 2200, Inc. | UDI-DI | 2022-11-02 | Class II | Under Investigation by firm | BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer’s IFU. This missing content is related to the interface with the device power supply, as well as cleaning | 40 units |
| Carefusion 2200, Inc. | UDI-DI | 2022-11-02 | Class II | Under Investigation by firm | BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer’s IFU. This missing content is related to the interface with the device power supply, as well as cleaning | 25 units |
| Carefusion 2200, Inc. | UDI-DI | 2022-11-02 | Class II | Under Investigation by firm | BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer’s IFU. This missing content is related to the interface with the device power supply, as well as cleaning | 46 units |
| Carefusion 2200, Inc. | UDI-DI | 2022-11-02 | Class II | Under Investigation by firm | BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer’s IFU. This missing content is related to the interface with the device power supply, as well as cleaning | 32 units |
| Carefusion 2200, Inc. | UDI-DI | 2022-11-02 | Class II | Under Investigation by firm | BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer’s IFU. This missing content is related to the interface with the device power supply, as well as cleaning | 35 units |
| Carefusion 2200, Inc. | UDI-DI | 2022-11-02 | Class II | Under Investigation by firm | BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer’s IFU. This missing content is related to the interface with the device power supply, as well as cleaning | 24 units |
| Carefusion 2200, Inc. | UDI-DI | 2022-11-02 | Class II | Under Investigation by firm | BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer’s IFU. This missing content is related to the interface with the device power supply, as well as cleaning | 19 units |
| Carefusion 2200, Inc. | UDI-DI | 2022-11-02 | Class II | Under Investigation by firm | BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer’s IFU. This missing content is related to the interface with the device power supply, as well as cleaning | 30 units |
| Carefusion 2200, Inc. | UDI-DI | 2022-11-02 | Class II | Under Investigation by firm | BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer’s IFU. This missing content is related to the interface with the device power supply, as well as cleaning | 21 units |
| Carefusion 2200, Inc. | UDI-DI | 2022-11-02 | Class II | Under Investigation by firm | BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer’s IFU. This missing content is related to the interface with the device power supply, as well as cleaning | 45 units |
| Carefusion 2200, Inc. | UDI-DI | 2022-11-02 | Class II | Under Investigation by firm | BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer’s IFU. This missing content is related to the interface with the device power supply, as well as cleaning | 28 units |
| Carefusion 2200, Inc. | UDI-DI | 2022-11-02 | Class II | Under Investigation by firm | BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer’s IFU. This missing content is related to the interface with the device power supply, as well as cleaning | 5 units |
| Carefusion 2200, Inc. | UDI-DI | 2022-11-02 | Class II | Under Investigation by firm | BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer’s IFU. This missing content is related to the interface with the device power supply, as well as cleaning | 79 units |
Showing 40 of 45.
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2022-10-17 | Class II | Component design/selection | Two electronic diode components (D1 & D4) placed in the reverse orientation on the controller printed circuit board assembly may result in premature wear of the power regulator, leading to the regulators failure which could cause a full pow | 5 units | 2024-05-28 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.