Medex
22 catalogue numbers from MX9616H000C1, listed by ICU Medical, Inc, United States, under Arterial Blood Sampling Kit. 1 manufacturer in China is registered for this product code.
1manufacturer
22catalogue numbers in this listing
2recalls on this code
Who Else Makes It
Registered in Zhejiang.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hantech Medical Device Co., Ltd. | Cixi | Zhejiang | Contract manufacturer | 18 |
Record
| Listed by | ICU Medical, Inc, United States |
|---|---|
| FDA product code | CBT |
| Device type | Arterial Blood Sampling Kit |
| Device class | Class 1 |
| Regulation | 21 CFR 868.1100 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K070340 |
| Record published | 2016-10-12 |
| Record revised | 2025-06-09 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Case of 10, case of 100 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| MX9616H000C1 | In distribution | |
| MX9515 | In distribution | |
| MX9625H003C1 | In distribution | |
| MX9535H003C1 | In distribution | |
| MX920NF | In distribution | |
| MX9514 | In distribution | |
| MX9613H001C1 | In distribution | |
| MX9545 | In distribution | |
| MX9647 | In distribution | |
| MX9515H001C1 | In distribution | |
| MXG300260 | In distribution | |
| MX9648 | In distribution | |
| MX9516 | In distribution | |
| MX9547 | In distribution | |
| MX9612H001C1 | In distribution | |
| MX9543 | In distribution | |
| MX9635H003C1 | In distribution | |
| MX9612 | In distribution | |
| MX9635H001C1 | In distribution | |
| MX9615 | In distribution | |
| MX9636H001C1 | In distribution | |
| MX9525H003C1 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Pulset | Westmed, Inc. | 49 |
| Medline | Medline Industries, Inc. | 24 |
| Centurion | Centurion Medical Products Corporation | 22 |
| Regard™ | Resource Optimization & Innovation, L.L.C. | 16 |
| AirLife™ | Airlife, Inc. | 16 |
| Deltran | Utah Medical Products, Inc. | 14 |
| A-Line | Westmed, Inc. | 12 |
| Pulset | SunMed Group Holdings, LLC | 11 |
| Atellica® VTR Syringes | SunMed Group Holdings, LLC | 7 |
| Blood Gas Sampler | Westmed, Inc. | 7 |
| Atellica® VTR Syringes | Westmed, Inc. | 5 |
| Arterial Blood Sampling Kit | Utah Medical Products, Inc. | 4 |
Showing 12 of 41. All products under Arterial Blood Sampling Kit
Recalls Naming This Product
8 recalls name this product by its own identifiers, the UDI on its label or the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Smiths Medical Asd, Inc. | 510(k) number | 2024-09-24 | Class II | Process control | Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a | 50 units |
| Smiths Medical Asd, Inc. | 510(k) number | 2024-09-24 | Class II | Process control | Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a | 400 units |
| Smiths Medical Asd, Inc. | 510(k) number | 2024-09-24 | Class II | Process control | Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a | 260 units |
| Smiths Medical Asd, Inc. | UDI-DI | 2024-09-24 | Class II | Process control | Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a | 800 units |
| Smiths Medical Asd, Inc. | UDI-DI | 2024-09-24 | Class II | Process control | Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a | 250 units |
| Smiths Medical Asd, Inc. | UDI-DI | 2024-09-24 | Class II | Process control | Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a | 3280 units |
| Smiths Medical Asd, Inc. | UDI-DI | 2024-09-24 | Class II | Process control | Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a | 1640 units |
| ICU Medical, Inc | 510(k) number | 2023-11-10 | Class II | Nonconforming Material/Component | There is a manufacturing defect affecting specific rotator lots. Within this population, the inner diameter of the devices O-ring may be oversized affecting seal integrity. An inadequate seal may lead to a leak during infusion of medication | 31,685 total |
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2007-11-21 | Not classified | Packaging process control | Misbranded; The product codes are labeled incorrectly with a green promotional label for “New split septum sampling site. Only use needle-free access devices …….”, however this product code contains a sampling site which is accessed wit | 1440 units | 2010-09-30 |
| 2007-11-21 | Not classified | Packaging process control | Misbranded; The product codes are labeled incorrectly with a green promotional label for “New split septum sampling site. Only use needle-free access devices …….”, however this product code contains a sampling site which is accessed wit | 250 units | 2010-09-30 |
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.