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.
FDA Recall Z-2346-2012 · Posted 2012-09-10
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Recalling FirmHospira, Inc.
Recall StatusTerminated
Product CodeMEA
Date Initiated2012-08-02
Date Terminated2014-05-08
Product Quantityunknown
Reason for Recall
Reports of leaking during filling and administration.
Firm Action
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
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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