FDA Device recall Z-1115-2022
Radiometer, REF:956-552, PIC050- Arterial Blood Sampler 1 X 2 mL, 80 IU electrolyte-balanced heparin
- FDA Device
- Class II
- ongoing
- Published 2022-05-25
On 2022-05-25 the FDA classified a Class II recall of Radiometer, REF:956-552, PIC050- Arterial Blood Sampler 1 X 2 mL, 80 IU electrolyte-balanced heparin by Radiometer Medical Aps, citing arterial Blood Sampler sterility cannot be guaranteed throughout the shelf life of the product.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1115-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-04-08 |
| Published | 2022-05-25 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Radiometer Medical Aps |
| Distribution | US |
Product
Radiometer, REF:956-552, PIC050- Arterial Blood Sampler 1 X 2 mL, 80 IU electrolyte-balanced heparin. Not for injection. , IVD, Rx Only, Sterile EO, CE
Reason
Arterial Blood Sampler sterility cannot be guaranteed throughout the shelf life of the product.
Identifiers
| code_info | "All Lots" UDI/DI: 05700699565525 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1115-2022%22
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