Dual Luer Lock Cap The device is intended for use as a cap for male or female Luer ports on medical devices such as mani

FDA device recall Z-0143-2014 · posted 2013-11-06 · Terminated

Recall details

Recalling firm

Baxter Healthcare Corp.

Reason for recall

The firm is recalling lots 10043 and 10044 due to loose particulate matter found in the packaging. Particulate matter entering the fluid path from the Luer lock caps may result in embolic events.

Action taken

Baxter sent an Urgent Product Recall notification dated September 16, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were advised to : 1. Locate and remove all affected product from your facility. If you distribute these products to other facilities or departments within your institution, please forward a copy of this communication to ensure that they locate and remove affected product from potential use.The product code and lot number can be found on the shipping carton label and individual product package. 2. Acknowledge your receipt of this recall notification by completing the attached Customer Reply Form (Attachment 1) and returning it to Baxter by either faxing it to 1-224-270-5457 or scanning and emailing it to fca@baxter.com. Returning the Customer Reply Form promptly will prevent you from receiving repeat notifications. 3. The affected product should be returned for credit by contacting Baxter Healthcare Center for Service. The Center for Service can be reached at 1-888-229-0001 between the hours of 7:00 am and 6:00 pm Central Time. Please have your Baxter eight-digit ship-to account number ready when calling. Please have the product code and lot number(s) available. 4.If you are a dealer, wholesaler,or distributor/reseller that distributed any product to other facilities, please forward this communication. Baxter distributed this product to customers between June 19, 2013 and August 20, 2013. The Center for One Baxter is available at 1-800-422-9837, Monday through Friday during the hours of 8:00 am to 5:00 pm Central Time.

Root cause

Employee error

Status

Terminated

Product code

OBK

Quantity affected

628,992 units

Distribution

Worldwide Distribution - USA (nationwide) and the country of Canada.

Date initiated

2013-09-10

Date posted

2013-11-06

Date terminated

2015-06-05

Location

Deerfield, IL