Rusch Flexi-slip tracheal tube Stylet, Size Ch 6, Sterile, Teleflex Medical.

FDA device recall Z-0246-2016 · posted 2015-11-06 · Terminated

Recall details

Recalling firm

Teleflex Medical

Reason for recall

Due to reports of the plastic coating of the stylet splitting and/or breaking off of the stylet.

Action taken

Consignees were notified by letter on 08/24/2015. They were instructed to immediately discontinue use and quarantine any products with the listed catalog numbers. They were to return the product, complete the enclosed Recall Acknowledgement Form and fax or e-mail to recalls@teleflex.com, even if they do not have any of the affected stock. Distributors were instructed to communicate the recall to any of their customers who have received the affected product and to have the customers return any affected product to them with the completed Recall Acknowledgement Form.

Root cause

Unknown/Undetermined by firm

Status

Terminated

Product code

BSR

Quantity affected

233,641 units

Distribution

Worldwide Distribution -- U.S. Nationwide; International Distribution: Argentina, Austria, Belgium, Belgrade, Cameroon, Canada, Chile, Costa Rica, Croatia, Czech Republic, Ecuador, Denmark, Estonia, F

Date initiated

2015-08-24

Date posted

2015-11-06

Date terminated

2017-09-25

Location

Research Triangle Park, NC