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.
This recall has been terminated (originally issued August 26, 2009).
- Company
- Teleflex Medical
- Recall Initiated
- July 6, 2009
- Posted
- August 26, 2009
- Terminated
- August 24, 2010
- Recall Number
- Z-1890-2009
- Quantity
- 1160 total
- Firm Location
- Durham, NC
- Official Source
- View on FDA website ↗
Reason for Recall
The Nasal Preformed Tracheal Tubes were found to have incorrect insertion depth mark printings.
Distribution
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.
Lot / Code Info
Lot number 01A0900364
Root Cause
Process control
Action Taken
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.