Sheridan Endotracheal Tube contained inside Centurion kit code TC7855
Centurion Medical Products Corporation began a recall of Sheridan Endotracheal Tube contained inside Centurion kit code TC7855 on . FDA classified it as Class I and gives the reason as "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". As of , the recall status on record is Terminated, and MDM tags the root cause as design.
Recall record
- Recall number
- Z-1956-2019
- Classification
- Class I
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Centurion Medical Products, LP
- Product
- Sheridan Endotracheal Tube contained inside Centurion kit code TC7855.
- Product code
- BTR Tube, Tracheal (W/Wo Connector)
- Reason for recall
- 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 tag
- design
- FDA root cause
- Device Design
- Action
- 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.
- Quantity in commerce
- 80 kits
- Distribution
- Distributed to one account in Arkansas.
- Product codes and lots
- Lot 2018110290
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-1956-2019 | Class I | Terminated | Voluntary: Firm initiated |
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