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Sterile Sheridan/HVT Cuffed, Murphy Eye, Tracheal Tube… recallZ-1938-2016 · Teleflex Medical · initiated May 5, 2016

Class II Terminated All recalls posted in June 2016

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Teleflex Medical or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

The labeling of some units indicates that it contains a size 7mm tracheal tube, but may contain a size 7.5mm tracheal tube.

FDA root cause category: Error in labeling

What the company is doing

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.

Recall details

Recall number
Z-1938-2016
Recall class
Class II
Status
Terminated
Initiated by the company
May 5, 2016
Posted by the FDA
Jun 9, 2016
Recalling firm
Teleflex Medical
Quantity
6,390 ea.
Product code
BTR
FDA submissions
K822082
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.

Product description

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.

Code information (models, lots, serial numbers)

Lot 73F1500606

Other devices under the same FDA submission

60 devices cleared under K822082 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page