PVC Thoracic Catheters
12 FR Right Angle – Soft PVC Catheter
1manufacturer
30catalogue numbers in this listing
1510(k) clearance
24recalls on this code
Who Else Makes It
Registered in Zhejiang. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Beilun Plastech Inc | Ningbo | Zhejiang | Contract manufacturer | 13 |
Record
| Listed by | Atrium Medical Corporation, United States |
|---|---|
| FDA product code | GBZ |
| Device type | Catheter, Cholangiography |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4200 |
| Establishment | Specification developer, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2020-09-22 |
| Record revised | 2024-07-31 (version 5) |
Specifications
| MRI safety | MR Safe |
|---|---|
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date |
| Sizes | Catheter gauge 8 to 40 Fr |
| Distribution end date | 2024-05-08 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 8112 | Catheter Gauge 12 Fr | In distribution |
| 8140 | Catheter Gauge 40 Fr | In distribution |
| 15032 | Catheter Gauge 32 Fr | In distribution |
| 8132 | Catheter Gauge 32 Fr | In distribution |
| 8116 | Catheter Gauge 16 Fr | In distribution |
| 8120 | Catheter Gauge 20 Fr | In distribution |
| 15028 | Catheter Gauge 28 Fr | In distribution |
| 8012 | Catheter Gauge 12 Fr | In distribution |
| 8136 | Catheter Gauge 36 Fr | In distribution |
| 8040 | Catheter Gauge 40 Fr | In distribution |
| 15020 | Catheter Gauge 20 Fr | In distribution |
| 8008 | Catheter Gauge 8 Fr | In distribution |
| 8020 | Catheter Gauge 20 Fr | In distribution |
| 8036 | Catheter Gauge 36 Fr | In distribution |
| 8128 | Catheter Gauge 28 Fr | In distribution |
| 8028 | Catheter Gauge 28 Fr | In distribution |
| 8124 | Catheter Gauge 24 Fr | In distribution |
| 8010 | Catheter Gauge 10 Fr | In distribution |
| 8024 | Catheter Gauge 24 Fr | In distribution |
| 15036 | Catheter Gauge 36 Fr | In distribution |
| 15024 | Catheter Gauge 24 Fr | In distribution |
| 8032 | Catheter Gauge 32 Fr | In distribution |
| 8016 | Catheter Gauge 16 Fr | In distribution |
| 15016 | Catheter Gauge 16 Fr | Withdrawn |
| 15232 | Catheter Gauge 32 Fr | Withdrawn |
| 15040 | Catheter Gauge 40 Fr | Withdrawn |
| 15228 | Catheter Gauge 28 Fr | Withdrawn |
| 15236 | Catheter Gauge 36 Fr | Withdrawn |
| 15224 | Catheter Gauge 24 Fr | Withdrawn |
| 15012 | Catheter Gauge 12 Fr | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Taut | Teleflex Medical LLC | 31 |
| Cook | Cook Incorporated | 12 |
| Reddick Scoop Tip Cholangiogram Catheter | Lemaitre Vascular, Inc. | 8 |
| Symmetry Surgical | Aspen Surgical Products, Inc. | 8 |
| PMI | Progressive Medical Technology, Inc. | 8 |
| Reddick Cholangiogram Catheter | Lemaitre Vascular, Inc. | 7 |
| Olsen | Cook Incorporated | 7 |
| Princeton | Princeton Medical Group, Inc. | 3 |
| RX Ercp Cannula | Boston Scientific Corporation | 2 |
| Metal Catheter | RZ Medizintechnik Gmbh | 2 |
| Catheter, Cholangiography | Edwards Lifesciences Technology Sarl | 2 |
| Petelin | Cook Incorporated | 1 |
Showing 12 of 32. All products under Catheter, Cholangiography
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K831931 | 1983-10-04 |
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Atrium Medical Corporation | UDI-DI | 2022-04-21 | Class II | Under Investigation by firm | Mismatch between the expiration date on the sterile barrier pouch and the expiration date on the case/shipper label. Product sterile barrier pouch label expiration date of 16SEP2024 (2024-09-16) while the case and shipper labels both showed | 56 cases (560 units / 10 units per case) |
Recalls
13 of these are 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 |
|---|---|---|---|---|---|
| 2026-08-07 | Not classified | Nonconforming Material/Component | An Out of Specification result (OOS) related to bacterial endotoxin testing in a single lot of catheters. | 3618 | |
| 2026-08-07 | Not classified | Nonconforming Material/Component | An Out of Specification result (OOS) related to bacterial endotoxin testing in a single lot of catheters. | 2533 | |
| 2026-08-07 | Not classified | Nonconforming Material/Component | An Out of Specification result (OOS) related to bacterial endotoxin testing in a single lot of catheters. | 256 | |
| 2023-09-29 | Class II | Nonconforming Material/Component | A sterilization nonconformance prematurely aged the product, resulting in an inaccurate labeled expiration date. | 2460 units (246 cases, 10 units/case) | |
| 2018-10-12 | Class II | Vendor change control | This recall has been initiated in response to a seal defect found in certain sterile barrier pouches containing the device. Affected pouches are un-sealed at the bottom. If the pouch defect is not detected it could represent a serious hazar | 2930 units | 2020-05-12 |
| 2017-01-20 | Class II | Labeling design | Labeling icon depicts a catheter having six (6) eyelets; however the correct number of eyelets on the 8 Fr and 10 Fr thoracic catheters is two (2) | 1394 cases (10/case) | 2020-11-03 |
| 2017-01-20 | Class II | Labeling design | Labeling icon depicts a catheter having six (6) eyelets; however the correct number of eyelets on the 8 Fr and 10 Fr thoracic catheters is two (2) | 660 cases (10/case) | 2020-11-03 |
| 2016-10-26 | Class II | Labeling design | Trocar Catheters are packaged with a label containing an icon that shows more holes (eyelets) than the product actually contains. | 1617 cases (10/cs) | 2018-10-09 |
| 2016-10-26 | Class II | Labeling design | Trocar Catheters are packaged with a label containing an icon that shows more holes (eyelets) than the product actually contains. | 7043 cases (10/cs) | 2018-10-09 |
| 2016-10-26 | Class II | Labeling design | Trocar Catheters are packaged with a label containing an icon that shows more holes (eyelets) than the product actually contains. | 2697 cases (10/cs) | 2018-10-09 |
| 2016-10-26 | Class II | Labeling design | Trocar Catheters are packaged with a label containing an icon that shows more holes (eyelets) than the product actually contains. | 4836 cases (10/cs) | 2018-10-09 |
| 2016-10-26 | Class II | Labeling design | Trocar Catheters are packaged with a label containing an icon that shows more holes (eyelets) than the product actually contains. | 2172 cases (10/cs) | 2018-10-09 |
| 2016-10-26 | Class II | Labeling design | Trocar Catheters are packaged with a label containing an icon that shows more holes (eyelets) than the product actually contains. | 2822 cases (10/cs) | 2018-10-09 |
| 2016-10-26 | Class II | Labeling design | Trocar Catheters are packaged with a label containing an icon that shows more holes (eyelets) than the product actually contains. | 5055 cases (10/cs) | 2018-10-09 |
| 2016-10-26 | Class II | Labeling design | Trocar Catheters are packaged with a label containing an icon that shows more holes (eyelets) than the product actually contains. | 5005 cases (10/cs) | 2018-10-09 |
| 2015-06-19 | Class II | Employee error | Inner pouches incorrectly labeled as part 8136, 36Fr Right Angled Thermosensitive PVC catheter, but are part 15236-36Fr Right Angled Firm PVC Catheter | 62 cases (10/cs)=620 units | 2016-03-21 |
| 2008-05-12 | Not classified | Nonconforming Material/Component | Heparin-coated Thoracic Catheters were manufactured with heparin allegedly contaminated with oversulfated chondroitin sulfate | 60 cases (10 individual/case) | 2009-08-20 |
| 2008-05-12 | Not classified | Nonconforming Material/Component | Heparin-coated Thoracic Catheters were manufactured with heparin allegedly contaminated with oversulfated chondroitin sulfate | 6 cases (10 individual/case) | 2009-08-20 |
| 2008-05-12 | Not classified | Nonconforming Material/Component | Heparin-coated Thoracic Catheters were manufactured with heparin allegedly contaminated with oversulfated chondroitin sulfate | 28 cases | 2009-08-20 |
| 2008-05-12 | Not classified | Nonconforming Material/Component | Heparin-coated Thoracic Catheters were manufactured with heparin allegedly contaminated with oversulfated chondroitin sulfate | 165 cases (10 individual/case) | 2009-08-20 |
| 2008-05-12 | Not classified | Nonconforming Material/Component | Heparin-coated Thoracic Catheters were manufactured with heparin allegedly conminated with oversulfated chondroitin sulfate | 10 cases (10 individual/case) | 2009-08-20 |
| 2008-05-12 | Not classified | Nonconforming Material/Component | Heparin-coated Thoracic Catheters were manufactured with heparin allegedly contaminated with oversulfated chondroitin sulfate | 10 cases (10 individual/case) | 2009-08-20 |
| 2008-05-12 | Not classified | Nonconforming Material/Component | Heparin-coated Thoracic Catheters were manufactured with heparin allegedly contaminated with oversulfated chondroitin sulfate | 252 cases (10 individual/case) | 2009-08-20 |
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.