Self-Righting Luer Lock Tip Cap, Green and Self-Righting Luer Slip Tip Cap, Yellow, Baxter Healthcare Corporation, 14445

FDA device recall Z-0871-2015 · posted 2014-12-24 · Terminated

Recall details

Recalling firm

Baxter Corporation Englewood

Reason for recall

Baxter Corporation initiated a recall of two lots of Self-Righting Luer Lock Tip Caps because they were distributed prior to closure of the validation.

Action taken

Baxter sent an Urgent Product Recall letter via USPS to all affected customers dated December 8, 2014.The letter identified the product the problem and the action needed to be taken by the customer. Customers are instructed to locate and remove all affected product from their facility, and to contact Baxter Healthcare to arrange for return and credit.Returned products will be destroyed./discarded. If you have questions regarding the content of the communication, please call The Center for One Baxter at (1-800) 422-9837, between the hours of 8:00am and 5:00pm Central time.

Root cause

Process control

Status

Terminated

Product code

KYX

Quantity affected

54,000

Distribution

Worldwide Distribution - US Distribution to the states of UT, TX, and IL, and to the countries Austria, Germany, Spain, Switzerland, and Netherlands. No VA/military/govt consignees.

Date initiated

2014-12-04

Date posted

2014-12-24

Date terminated

2016-11-30

Location

Englewood, CO