Sheridan/CF Cuffed Tracheal Tube, Sterile, Rx only, Teleflex Medical, Research Triangle Park, NC 27708. Designed for ora

FDA device recall Z-0799-2015 · posted 2014-12-12 · Terminated

Recall details

Recalling firm

Teleflex Medical

Reason for recall

Product Labeling; Units from the affected lot indicates that it contains a size 8mm tracheal tube but may contain a size 7.5mm tracheal tube.

Action taken

Consignees were notified by an Urgent Medical Device Recall Notification letter on 11/12/2014. The letter identified the affected product, as well as, the reason for the recall. Customers are instructed to immediately discontinue use of and quarantine any affected product. They are also instructed to complete and fax or e-mail the enclosed Recall Acknowledgement Form regardless of whether they have affected product in stock or not. Upon receipt of the form, a customer service representative will contact customers to provide an RGA number, as well as, instructions for the return of the product. A local sales representative or customer service should be contacted with questions at 1-866-246-6990.

Root cause

Process control

Status

Terminated

Product code

BTR

Quantity affected

14,000 units

Distribution

Worldwide Distribution -- U.S., Belgium, Canada, and Japan.

Date initiated

2014-11-12

Date posted

2014-12-12

Date terminated

2017-10-13

Location

Durham, NC

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