smiths medical medex CBSS-5ML — Class II medical device recall Z-0102-2022
Terminated recall by Smiths Medical ASD Inc., reported 2021-10-20. Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets.
| Recall number | Z-0102-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Smiths Medical ASD Inc., Minneapolis, MN, United States |
| Recall initiated | 2020-03-10 |
| Classified | 2021-10-13 |
| Reported by FDA | 2021-10-20 |
| Terminated | 2023-09-22 |
| Countries outside the US | AT, DE, FR, GB, SA |
| Quantity | 13,620 units |
| Model numbers | DPSHC0093 |
Product
smiths medical medex CBSS-5ML, Single Set, (172/15cm), Model Number DPSHC0093
Reason for recall
Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets.
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-0102-2022. 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.