PIC070 Arterial Blood Sampler PICO70 — Class II medical device recall Z-1683-2021
Terminated recall by Radiometer Medical ApS, reported 2021-06-02, distributed nationwide. Radiometer has become aware of an issue with PICO70 Arterial Blood Sampler. The issue relates to the sterile b
| Recall number | Z-1683-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Radiometer Medical ApS, Bronshoj, N/A, Denmark |
| Recall initiated | 2021-03-26 |
| Classified | 2021-05-26 |
| Reported by FDA | 2021-06-02 |
| Terminated | 2023-03-01 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BE, BH, CA, CH, CN, CO, CR, CZ, DE, DK, DZ, ES, FI, FR, GB, GR, GT, HR, HU, ID, IN, IS, IT, JP, LB, LT, LU, MX, NL, NO, NZ, OM, PE, PL, RO, RU, SA, SE, SK, TR, TW, ZA |
| Reason classes | microbial contamination, sterility |
| Model numbers | PICO70 |
Product
PIC070 Arterial Blood Sampler PICO70 - Product Usage: Preheparinized, electrolyte-balanced, arterial blood sampler product line for collection of arterial samples for pH, blood gas, oximetry, electrolyte and metabolite analysis. Model Number/Product Description: 956-518 PICO70 w/o needle; 956-519 PICO70 w/o needle; 956-522 PICO70 22G x 25 mm; 956-525 PICO70 22G x 32 mm; 956-529 PICO70 23G x 16 mm; 956-533 PICO70 23G x 25 mm; 956-534 PICO70 23G x 32 mm; 956-547 PICO70 25G x 16 mm;
Reason for recall
Radiometer has become aware of an issue with PICO70 Arterial Blood Sampler. The issue relates to the sterile barrier system for the product. During internal stress testing on PICO70 Arterial Blood Samplers a breach in the sterile barrier system was observed in one sample. Risk for the patient: The described error is considered to have a remote possibility of resulting in bacterial bloodstream infection. The bloodstream infection may be asymptomatic but may also progress to sepsis or life-threatening septic shock. Immunosuppressed patients are at particular risk. Due to issues (breaches) with the sterile barrier system for the Arterial Blood Sampler.
Machine access
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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.