Sterile Sheridan/HVT Cuffed, Murphy Eye, Tracheal Tube, Ref: V5-10314, ID: 7.0 mm, Rx Only, Manufactured by: Teleflex Incorporated. A tracheal tube is inserted into a patients mouth or nose for airway management.
FDA Recall Z-1938-2016 · Posted 2016-06-09
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Recalling FirmTeleflex Medical
Recall StatusTerminated
Product CodeBTR
Date Initiated2016-05-05
Date Terminated2017-08-25
Product Quantity6,390 ea.
Reason for Recall
The labeling of some units indicates that it contains a size 7mm tracheal tube, but may contain a size 7.5mm tracheal tube.
Firm Action
The firm, Teleflex Medical, sent an "Urgent Medical Device Recall Notification" letter dated May 5, 2016 to its accounts/customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately discontinue distribution and quarantine product; communicate this recall to any of your customers who have received product; have your customers return to you any affected product with Recall Acknowledgement Form; contact Teleflex Medical Customer Service for more information at 1-866-246-6990; and complete and return Recall Acknowledgment Form via fax to 1-855-419-850, Attn: Customer Service or email to [email protected], even if you and your customers have no affected stock/product. Teleflex will provide you with instructions for the return of product.
If you have any other questions, feel free to contact your local sales representative or Customer Service at 1-866-246-6990.
Root Cause
Error in labeling
Distribution Pattern
US Distribution to states of: AL, AZ, CO, FL, GA, ID, IL, IN, IA, KY, LA, MD, MA, MI, MN, MO, NY, NC, OK, PA, RI, TX and UT.
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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