Recall Z-2395-2012 ยท KPE Container, I.V.
Hospira Inc.
Empty Evacuated Container 250 mL and 1000 mL. Empty Evacuated containers are used for mixing compatible medications or blood collections.
| Date | Sep 17, 2012 (initiated Aug 28, 2012) |
| Status | Terminated |
| Reason | Embedded iron oxide glass defect which may have the potential to break off into the solution. |
| Root cause | Material/Component Contamination |
| Action | 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. |
| Quantity | 191,094 units |
| Distribution | Worldwide Distribution-USA (nationwide) and the countries of Saudi Arabia, Canada and Barbados. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.