Retiro De Equipo (Recall) de Device Recall Baxter

Recall

70128

Class 2

Z-1227-2015

2014-12-29

2015-02-27

Terminated

United States

2016-08-08

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=132282

Self-righting luer tip caps were manufactured and shipped with a missing latex symbol on both single and case labels.

Baxter sent an Safety Alert letter dated January 15, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Baxter is requesting that you take the following actions: 1.Complete the enclosed customer reply form and return it to Baxter by faxing it to 224-270-5457 or scanning and e-mailing it to fca@baxter.com. Returning the customer reply form promptly will prevent you from receiving repeat notices. 2. Please forward a copy of this Safety Alert letter to other facilities or departments within your institutions to ensure that those locations are aware of this action. Action to be taken if you are an end-user and purchased product from a distributor or reseller: 1. Please forward a copy of this Safety Alert letter to other facilities or departments within your institutions to ensure that those locations are aware of this action. 2. Follow your supplier's reply process. Please do not return the customer reply form to Baxter. Action to be taken if you are a distributor: If you are a dealer, wholesaler, or distributor/reseller that distributed any product to other facilities, please notify your customers of this Safety Alert in accordance with your customary procedures. Further information and support For general questions regarding this communication, contact The Center for One Baxter at 800-422-9837, Monday through Friday, between the hours of 8:00 AM and 5:00 PM Central Time.