—#131480

Product

Sheridan/CF Cuffed Tracheal Tube, Sterile, Rx only, Teleflex Medical, Research Triangle Park, NC 27708. Designed for oral and nasal intubation and are indicated for airway management.

FDA product code: BTR — Tube, Tracheal (W/Wo Connector)
Device class: Class 2
Medical specialty: Anesthesiology
510(k) numbers: K822082
Affected lot / code info: Product Code: 5-10116, Lot number: 01A1400211

Why it was recalled

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.

Root cause (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm: Teleflex Medical
Address: 4024 Stirrup Creek Dr, Durham, North Carolina 27703-9000

Distribution

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

Timeline

Recall initiated: 2014-11-12
Posted by FDA: 2014-12-12
Terminated: 2017-10-13
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #131480. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.