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Sheridan Endotracheal Tube contained inside Centurion kit… recallZ-1956-2019 · Centurion Medical Products Corporation · initiated Jun 7, 2019

Class I Terminated All recalls posted in July 2019

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 Centurion Medical Products Corporation 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

Centurion is conducting a sub-recall for Teleflex Sheridan branded Endotracheal Tracheal Tubes due to increased incidence of Sheridan connector becoming disconnected from Endotracheal Tube.

FDA root cause category: Device Design

What the company is doing

On June 7, 2019, Centurion notified Medline (the distributor) that they were conducting a recall via an Urgent Product Recall Notice. Medline was instructed to cease further distribution and to notify any customers who received this product. On June 14, 2019, Medline informed its customer of the recall via a letter titled "CENTURION MEDICAL PRODUCT SUB-RECALL*** IMMEDIATE ACTION REQUIRED". REQUIRED ACTION FOR CUSTOMERS: 1. Immediately check your stock for the affected item number and the affected lot number listed on the attachment. Quarantine all affected product. 2. Please return the completed enclosed response form listing the quantity of affected product on hand. Even if you do not have any affected product please complete and return the form, as indicated on the response form. When we receive your completed response form you will be sent return labels (if applicable). Your account will receive credit when the returned product is received. 3. If you have transferred possession of this product to another individual, to another department or another location in your organization you are required by FDA regulations to notify them of this recall communication. Have the customers return any affected product to you for collection and return to Medline Industries, Inc. ***Updated 8/2/19*** In July 2019, due to an amendment to the letter from Teleflex, the supplier, Centurion sent a revised letter to Medline, who likewise sent a revised letter to customers. The revised letter contained additional information pertaining to the risk associated with the recalled product. If you have any questions, please contact the firm at 866-359-1704.

Recall details

Recall number
Z-1956-2019
Recall class
Class I (most serious)
Status
Terminated
Initiated by the company
Jun 7, 2019
Posted by the FDA
Jul 30, 2019
Recalling firm
Centurion Medical Products Corporation
Quantity
80 kits
Product code
BTR
FDA submissions
K091761, K822082
Distribution
Distributed to one account in Arkansas.

Product description

Sheridan Endotracheal Tube contained inside Centurion kit code TC7855.

Code information (models, lots, serial numbers)

Lot 2018110290

Other devices under the same FDA submission

60 devices cleared under K091761, 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

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