Baxter Non-DEHP Y-Type Catheter Extension Set, 5.3" (13.5 cm), 1.0 mL, Male Luer Lock Adapter with Retractable Collar; a

FDA device recall Z-0149-2011 · posted 2010-10-27 · Terminated

Recall details

Recalling firm

Baxter Healthcare Corp.

Reason for recall

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.

Action taken

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 customer reply form confirming their receipt of the letter and fax it to Baxter at the number provided on the form. Dealers, wholesalers and distributors were requested to notify their customers of this action so they could comply with the procedures listed above. Any questions regarding the communication were directed to The Center for One Baxter at 1-800-422-9837 during the hours of 8:00 am to 5:00 pm CST.

Root cause

Package design/selection

Status

Terminated

Product code

FPA

Quantity affected

413,750 sets

Distribution

Worldwide Distribution - U.S., Canada, Japan, Australia, New Zealand, and Chile.

Date initiated

2010-09-09

Date posted

2010-10-27

Date terminated

2011-09-07

Location

Round Lake, IL

Related 510(k) clearances