Sheridan Preformed Cuffed Tracheal Tube, Nasal 7.0, Catalog Number: 5-22314, Teleflex Medical Ltd, Research Triangle Park, NC 27709 Used for oral or nasal intubation for airway management.
FDA Recall Z-1891-2009 · Posted 2009-08-26
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Recalling FirmTeleflex Medical
Recall StatusTerminated
Product CodeBTR
Date Initiated2009-07-06
Date Terminated2010-08-24
Product Quantity1160 total
Reason for Recall
The Nasal Preformed Tracheal Tubes were found to have incorrect insertion depth mark printings.
Firm Action
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.
Root Cause
Process control
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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