—#83993

Product

Sheridan Preformed Cuffed Tracheal Tube, Nasal 6.5, Catalog Number: 5-22313, Teleflex Medical Ltd, Research Triangle Park, NC 27709 Used for oral or nasal intubation 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: Lot number 01A0900364

Why it was recalled

The Nasal Preformed Tracheal Tubes were found to have incorrect insertion depth mark printings.

Root cause (FDA determination)

Process control

Action the firm took

Consignees were notified by an Urgent Medical Device Recall letter on/about 07/06/2009. They were instructed to discontinue use of and return any of the recalled product to Teleflex Medical. Distributors were advised to forward the letter to their consignees to retrieve relevant product from those locations. A Recall Acknowledgement Form was attached to be returned to Teleflex Medical. Replacement product or credit will be provided to the consignee.

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution -- USA, including states of CA, FL, IL, KY, MA, NC, NM, NJ, OH, PA, RI, TN, TX, UT, VA, WA, and WI and countries of France and Japan.

Timeline

Recall initiated: 2009-07-06
Posted by FDA: 2009-08-26
Terminated: 2010-08-24
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #83993. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.