Rusch Flexi-slip Endotracheal Tube Stylet with Soft Distal Tip, 6FR, Catalog numbers: 502501, Teleflex Medical Sdn Bhd,

FDA device recall Z-0517-2012 · posted 2012-01-11 · Terminated

Recall details

Recalling firm

Teleflex Medical

Reason for recall

Complaints of difficulty removing stylet from the endotracheal tube and possible PVC sheath separation were received.

Action taken

The firm, Teleflex Medical, sent an "Urgent Medical Device Recall Notification" letter dated December 2, 2011 to its Consignees/Customers. The letter described the product, problem and actions to be take. The customers were instructed to immediately discontinue use and quarantine any products with the listed catalog and lot numbers; return the product; complete and return the enclosed Immediate Attention Requested Recall Acknowledgement Form via fax to 1-866-804-9881, Attn: Customer Service (a customer service representative will contact the customer with a returns good authorization number and provide instructions for the return of product to Teleflex medical), even if they have no affected product. If you have any other questions, feel free to contact your local sales representative or Customer Service at 1-866-246-6990.

Root cause

Pending

Status

Terminated

Product code

BSR

Quantity affected

73,281 units

Distribution

Worldwide distribution: USA (nationwide) and countries of: Canada and Europe.

Date initiated

2011-12-02

Date posted

2012-01-11

Date terminated

2014-04-29

Location

Research Triangle Park, NC