Recall Z-0154-2011 ยท FPA Set, Administration, Intravascular
Baxter Healthcare Corp.
Baxter Non-DEHP I.V. Catheter Extension Set, 8.2" (20.9 cm), 0.3 mL, PosiFlow Positive Displacement Access Device for I.V. Access, Male Luer Lock Adapter; an Rx sterile device; Baxter Healthcare Corporation, Deerfield, IL 60015 USA; product 2N9051 For the administration of drugs and solutions to a patient's vascular system through a vascular access device.
| Date | Oct 27, 2010 (initiated Sep 9, 2010) |
| Status | Terminated |
| Reason | During packaging testing, Baxter observed tears and pinholes in Chevron-style pouches for certain infusion disposable products. The pinholes and tears could compromise the sterile barrier properties of the pouch. |
| Root cause | Package design/selection |
| Action | Baxter Healthcare Corporation sent an Urgent Product Recall letter dated September 9, 2010, to all customers. The letter identified the product, the problem and the action to be taken by the customer. The customers were requested to examine their inventory in all locations to determine if they had any of the affected lots of the affected product codes and to remove the affected product from their inventory; they were to call the Baxter Healthcare Center for Service at 1-888-229-0001 to return the affected product, request a credit, or request replacement product; complete the attached custom |
| Quantity | 498,850 sets |
| Distribution | Worldwide Distribution - U.S., Canada, Japan, Australia, New Zealand, and Chile. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K964918 | NIMA NEEDLELESS INJECTIONSITE MASTER ADAPTER WITH POSIFLOW POSITIVE DISPLACEMENT FEATURE, AND I.V. SETS Critical Device Corp., Apr 14, 1997 |