Radiometer — Class II medical device recall Z-1115-2022
Ongoing recall by Radiometer Medical ApS, reported 2022-05-25, distributed nationwide. Arterial Blood Sampler sterility cannot be guaranteed throughout the shelf life of the product.
| Recall number | Z-1115-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Radiometer Medical ApS, Bronshoj, N/A, Denmark |
| Recall initiated | 2022-04-08 |
| Classified | 2022-05-19 |
| Reported by FDA | 2022-05-25 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AT, AU, BE, BO, BR, CA, CH, CL, CN, CO, CY, CZ, DE, DK, DZ, EC, EE, EG, ES, FI, FR, GB, GR, GT, HK, HR, HU, IE, IL, IN, IS, IT, JP, LB, LT, MY, NI, NL, NO, PL, PT, RO, RS, RU, SE, SI, SK, TH, TR, UY, VN, ZA |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 05700699565525 |
| Model numbers | 956-552, PIC050 |
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 for recall
Arterial Blood Sampler sterility cannot be guaranteed throughout the shelf life of the product.
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-1115-2022. 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.