Medstream 81" — Class II medical device recall Z-1277-2015
Terminated recall by US Infusion Inc dba Trucare Biomedix-USA, reported 2015-03-25, distributed in CA, GA, IL, MA, OH, TX. Several complaints regarding the IV sets leaking at the Y site.
| Recall number | Z-1277-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | US Infusion Inc dba Trucare Biomedix-USA, South Miami, FL, United States |
| Recall initiated | 2014-10-10 |
| Classified | 2015-03-13 |
| Reported by FDA | 2015-03-25 |
| Terminated | 2015-06-23 |
| Distributed | CA, GA, IL, MA, OH, TX |
| Quantity | 62,700 iv |
| Reason classes | packaging |
| Lot numbers | 20111115 |
| Model numbers | MS721 |
Product
Medstream 81" (206 cm) 20 drop Universal Administration Sets. Disposable IV infusion set with 3 year expiration date.
Reason for recall
Several complaints regarding the IV sets leaking at the Y site.
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-1277-2015. 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.