Recalls / —
—#112021
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.
- FDA product code
- MEA — Pump, Infusion, Pca
- Device class
- Class 2
- Medical specialty
- General Hospital
- 510(k) numbers
- K043256
- Affected lot / code info
- 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.
Why it was recalled
Reports of leaking during filling and administration.
Root cause (FDA determination)
Nonconforming Material/Component
Action the firm took
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.
Recalling firm
- Firm
- Hospira, Inc.
- Address
- 600 N Field Dr, Bldg J45, Lake Forest, Illinois 60045
Distribution
- 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.
Timeline
- Recall initiated
- 2012-08-02
- Posted by FDA
- 2012-09-10
- Terminated
- 2014-05-08
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #112021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.