FDA Medical Device Recalls (openFDA)
Teleflex Medical: 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.
- Recall number
- Z-1938-2016
- Recalling firm
- Teleflex Medical
- Product
- 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.
- Status
- Terminated
- Initiated
- 2016-05-05
- Posted
- 2016-06-09
- Terminated
- 2017-08-25
- Reason
- The labeling of some units indicates that it contains a size 7mm tracheal tube, but may contain a size 7.5mm tracheal tube.
- Root cause
- Error in labeling
- 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 recalls@teleflex.com, 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.
- Quantity
- 6,390 ea.
- Distribution
- 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.
- Lot, serial or model codes
- Lot 73F1500606
- 510(k) numbers
- ["K822082"]
- PMA numbers
- not on file
- Product code
- BTR
- Firm FEI
- 3005747797
- Firm city
- Research Triangle Park
- Firm state
- NC
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28