Sterile Empty Vial and Injector — Class II medical device recall Z-2346-2012
Terminated recall by Hospira, Inc., reported 2012-09-19, distributed in AL, AR, AZ, CA, CO, CT, DE, FL…. Reports of leaking during filling and administration.
| Recall number | Z-2346-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hospira, Inc., Lake Forest, IL, United States |
| Recall initiated | 2012-08-02 |
| Classified | 2012-09-10 |
| Reported by FDA | 2012-09-19 |
| Terminated | 2014-05-08 |
| Distributed | AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, WY |
| Countries outside the US | CA, CR |
| Reason classes | packaging |
Product
Sterile Empty Vial and Injector (30mL PCA vial), Rx only, One/List No. 6021-03, Hospira, Inc., Lake Forest, IL 60045. For use with a compatible Hospira PCA pump set with injector and a compatible Hospira infusion device.
Reason for recall
Reports of leaking during filling and administration.
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-2346-2012. 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.