Gang Cath Lab Set — Class II medical device recall Z-1474-2021
Terminated recall by Smiths Medical ASD Inc., reported 2021-04-28, distributed nationwide. Specific lots of Medex High Pressure Adaptors, Rotators, Manifolds, Stopcocks and Tubing and Medex LogiCal Kit
| Recall number | Z-1474-2021 |
|---|---|
| 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 | 2021-03-31 |
| Classified | 2021-04-21 |
| Reported by FDA | 2021-04-28 |
| Terminated | 2023-03-20 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, BR, CA, CL, CO, EC, HK, JP, MX, SI, ZA |
| Quantity | 400 devices |
| Lot numbers | 4007165 |
| Model numbers | M20858R1.FOR |
Product
Gang Cath Lab Set, Model Number M20858R1.for the administration of IV fluids. Stopcocks and manifolds are used to control the direction of IV fluid flow.
Reason for recall
Specific lots of Medex High Pressure Adaptors, Rotators, Manifolds, Stopcocks and Tubing and Medex LogiCal Kits may have been manufactured with insufficient or incomplete welds. These are components for various cardiac kits including pressure monitoring devices and interventional imaging devices.
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-1474-2021. 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.