127" — Class II medical device recall Z-1593-2015
Terminated recall by ICU Medical, Inc., reported 2015-05-13, distributed nationwide. ICU Medical is recalling MicroClave T-Connectors because they have potential connection separation issues that
| Recall number | Z-1593-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | ICU Medical, Inc., San Clemente, CA, United States |
| Recall initiated | 2015-04-20 |
| Classified | 2015-05-07 |
| Reported by FDA | 2015-05-13 |
| Terminated | 2015-11-24 |
| Distributed | Nationwide (US) |
| Quantity | 5,100 units |
| Reason classes | packaging |
| Lot numbers | 2997914, 2997918, 2998570, 3001230, 3001231 |
| Model numbers | B33351 |
Product
127" (323cm) Transfer Set w/Check Valve, MicroClave T-Connector, Anti-Siphon Valve, Clamp, Luer Lock, Non-DEHP Tubing, Item No. B33351 Product Usage: IV Administration sets are intended for the infusion and withdrawal of fluids. The devices are provided sterile.
Reason for recall
ICU Medical is recalling MicroClave T-Connectors because they have potential connection separation issues that could lead to leakage.
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-1593-2015. 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.