Portex Pro-Vent Arterial Blood Sampling Kit with Dry Lithium Heparin… — Class II medical device recall Z-0141-2024
Ongoing recall by Smiths Medical ASD Inc., reported 2023-11-01. The complaint involved the absence of a component called "ASM Filter-Pro ABG SYR CAP" from the packaging of Pr
| Recall number | Z-0141-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Smiths Medical ASD Inc., Minneapolis, MN, United States |
| Recall initiated | 2023-09-06 |
| Classified | 2023-10-20 |
| Reported by FDA | 2023-11-01 |
| Quantity | 31,900 devices |
| UPC / GTIN / UDI-DI | 30351688028635 |
| Lot numbers | 4331283 |
| Model numbers | 4599P-1 |
Product
Portex Pro-Vent Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes, REF 4599P-1
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0141-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.