Portex Pro-Vent Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes, REF 4599P-1
FDA device recall Z-0141-2024 · posted 2023-10-20 · Open, Classified
Recall details
- Recalling firm
- Smiths Medical ASD Inc.
- Reason for recall
- The complaint involved the absence of a component called "ASM Filter-Pro ABG SYR CAP" from the packaging of Pro-Vent Arterial Blood Sampling (ABG) Kits. Specifically, this issue affected a total of 31,900 kits under the FGSKU# 4599P-1 and Lot# 4331283. Tubes without caps have the potential to generate delayed or erroneous test results and/or exposure to infectious blood.
- Action taken
- Smiths Medical issued an URGENT MEDICAL DEVICE RECALL notice to its consignees on 09/06/2023 by mail. The notice explained the problem with the device, potential risk, and requested the following: 1. Discontinue use, distribution, and quarantine all affected product in inventory. 2. Notify all potential users within the consignee organization 3. Distributors were directed to notify their customers. Questions: Customer Service 1-(800)-258-5361
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- JKA
- Quantity affected
- 31900 devices
- Distribution
- US
- Date initiated
- 2023-09-06
- Date posted
- 2023-10-20
- Location
- Minneapolis, MN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PRO-VENT, LINE DRAW, PULSATOR (K952516) | Smiths Industries Medical Systems, Inc. | 1995-07-14 |