Sterile Empty Vial and Injector (30mL PCA vial), Rx only, One/List No. 6021-03, Hospira, Inc., Lake Forest, IL 60045. Fo
FDA device recall Z-2346-2012 · posted 2012-09-10 · Terminated
Recall details
- Recalling firm
- Hospira, Inc.
- Reason for recall
- Reports of leaking during filling and administration.
- Action taken
- Hospira sent an Urgent Device Field Correction letter dated August 3, 2012, to all affected customers. The letter identifed the product, the probem, and the action to be taken by the customer. Customers were instructed to first consider the use of Prefilled Morphine PCA Vials wherever possible. In some instances, the treating physician may require an alternative to morphine. Customers may continue using the affected product by following the instructions provided in the Correction Letter. Customers were asked to complete the attached Reply Form and fax it to 1-888-879-8144. For questions regarding this recall call 877-946-7747.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- MEA
- Quantity affected
- unknown
- Distribution
- Worldwide Distribution - USA including AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NY, NC, NK, OH, OK, OR, PA, PR, RI, SC, SD, T
- Date initiated
- 2012-08-02
- Date posted
- 2012-09-10
- Date terminated
- 2014-05-08
- Location
- Lake Forest, IL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HOSPIRA LIFECARE INFUSION SYSTEM, MODEL 12384-04-07; LIFECARE PCA INFUSION SYSTEM STERILE EMPY VIALS, MODEL 6021-04-03 (K043256) | Hospira, Inc. | 2004-12-06 |