Recall Z-2346-2012
Hospira, Inc. · initiated August 2, 2012
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: The letter was issued for all product presently in the field and product that will be released. Specific lot numbers were not indicated in the letter.
Reason for recall
Reports of leaking during filling and administration.
FDA-determined cause: Nonconforming Material/Component
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.
Details
- Recall number
- Z-2346-2012
- Initiated
- August 2, 2012
- Posted by FDA
- September 10, 2012
- Terminated
- May 8, 2014
- Product code
- MEA – Pump, Infusion, Pca
- Quantity
- 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, TN, TX, UT, VA, WA, WI, and WY and the countries of Canada, Costa Rica and the Virgin Islands.
- Recalling firm
- Hospira, Inc., Lake Forest, IL