Recall Z-1529-2010 ยท KPE Container, I.V.
Baxter Healthcare Corp.
Baxter Evacuated Container, 250 mL, Sterile, non pyrogenic, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, Made in USA, product code 1A8502.
| Date | Apr 29, 2010 (initiated Feb 15, 2010) |
| Status | Terminated |
| Reason | Routine stability testing of the evacuated container product, along with trending of results, indicates that the pH will exceed the upper specification limit prior to the expiration date of this product. |
| Root cause | Nonconforming Material/Component |
| Action | Urgent Product Recall letters dated 2/15/10 were mailed on the same date via first class mail to the affected direct accounts to the attention of the Director of Pharmacy, the Director of Materials Management, and the Director of Risk Management. The accounts were informed of the potential for the pH of the products to exceed the upper specification limits for pH prior to the product expiration date. The accounts were requested discontinue use and segregate the affected lots of products from inventory and call Baxter Healthcare Center for Service at 1-888-229-0001, Monday through Friday, 7:00 |
| Quantity | 64,560 units |
| Distribution | United States -- Nationwide and Puerto Rico, Canada and Saudi Arabia |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.