Recall Z-2395-2012
Hospira Inc. · initiated August 28, 2012
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Empty Evacuated Container 250 mL and 1000 mL. Empty Evacuated containers are used for mixing compatible medications or blood collections.
Codes / lots: 250 mL size - Lot 11179DW, Exp, Date 1NOV2013, 11195DW, Exp. Date 1NOV2013 and 93854DW, Exp. Date 1SEP2012 - 1000 mL size - Lot 92835DW, Exp. Date 1AUG2012, Lot 96090DW, Exp. Date 1DEC2012, and Lot 96098DW, Exp. Date 1DEC2012
Reason for recall
Embedded iron oxide glass defect which may have the potential to break off into the solution.
FDA-determined cause: Material/Component Contamination
Action taken
Hospira sent an "URGENT DEVICE RECALL" dated August 28, 2012 to all affected customers. The letter identified the product, problem,and actions to be taken by the customers. The letter included an Urgent Device Recall Reply Form for customers to complete and return via fax to 1-888-237-5582. Contact Hospira Customer Care at 1-877-946-7747 for questions regarding this recall.
Details
- Recall number
- Z-2395-2012
- Initiated
- August 28, 2012
- Posted by FDA
- September 17, 2012
- Terminated
- September 18, 2013
- Product code
- KPE – Container, I.V.
- Quantity
- 191,094 units
- Distribution
- Worldwide Distribution-USA (nationwide) and the countries of Saudi Arabia, Canada and Barbados.
- Recalling firm
- Hospira Inc., Lake Forest, IL