Recall Z-0148-2011 ยท FPA Set, Administration, Intravascular
Baxter Healthcare Corp.
Baxter Clearlink System Non-DEHP Y-Type Catheter Extension Set, 6.5" (16.5 cm), Vol 1.2 mL, Luer Activated Valve for I.V. Access, Male Luer Lock Adapter with Retractable Collar; an Rx sterile device; Manufactured by an affiliate of Baxter Healthcare Corporation, Deerfield, IL 60015 USA, Made in Costa Rica; product 2N8377 For the administration of drugs and solutions to a patient's vascular system
| 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 | 72,136 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
| K003225 | SOLUTION ADMINISTRATION SETS WITH CAPLESS LUER ACTIVATED VALVE Baxter Healthcare Corp, Oct 19, 2000 |