—#174007

Product

Sheridan Endotracheal Tube contained inside Centurion kit code TC7855.

FDA product code: BTR — Tube, Tracheal (W/Wo Connector)
Device class: Class 2
Medical specialty: Anesthesiology
510(k) numbers: K091761, K822082
Affected lot / code info: Lot 2018110290

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.

Root cause (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm: Centurion Medical Products Corporation
Address: 100 Centurion Way, Williamston, Michigan 48895-9086

Distribution

Distribution pattern: Distributed to one account in Arkansas.

Timeline

Recall initiated: 2019-06-07
Posted by FDA: 2019-07-30
Terminated: 2020-07-28
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #174007. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.