Empty Evacuated Container 250 mL and 1000 mL — Class II medical device recall Z-2395-2012
Terminated recall by Hospira Inc., reported 2012-09-26, distributed nationwide. Embedded iron oxide glass defect which may have the potential to break off into the solution.
| Recall number | Z-2395-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hospira Inc., Lake Forest, IL, United States |
| Recall initiated | 2012-08-28 |
| Classified | 2012-09-17 |
| Reported by FDA | 2012-09-26 |
| Terminated | 2013-09-18 |
| Distributed | Nationwide (US) |
| Countries outside the US | BB, CA, SA |
| Quantity | 191,094 units |
| Reason classes | foreign material, device malfunction |
| Lot numbers | 1000, 11179DW, 11195DW, 1NOV2013, 92835DW, 93854DW, 96090DW, 96098DW |
| Expiration dates | 2012-08-01, 2012-09-01, 2012-12-01, 2013-11-01 |
Product
Empty Evacuated Container 250 mL and 1000 mL. Empty Evacuated containers are used for mixing compatible medications or blood collections.
Reason for recall
Embedded iron oxide glass defect which may have the potential to break off into the solution.
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-2395-2012. 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.