Recall Z-1959-2023 ยท BTR Tube, Tracheal (W/Wo Connector)
TELEFLEX LLC
Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080060
| Date | Jun 29, 2023 (initiated May 25, 2023) |
| Status | Open, Classified |
| Reason | Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products. |
| Root cause | Under Investigation by firm |
| Action | Teleflex issued an URGENT MEDICAL DEVICE RECALL notice to its consignees on 05/25/2012 by FedEx. The notice explained the problem, the risk, and requested the following: Users should cease use and distribution of affected product and immediately quarantine the affected product. Distributors were directed to cease use, distribution, and quarantine the product, and to notify their customers. Teleflex is seeking the return of the affected product. For further information: Contact: Customer Service, Telephone: 1-866-396-2111 FAX: 1-855-419-8507, Email: Recalls@teleflex.com |
| Quantity | 4160 units |
| Distribution | US Nationwide distribution including Puerto Rico. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K961837 | RUSH ORAL/NASAL TRACHEAL TUBE CUFFED MAGILL/MURPHY Rusch Intl., Aug 16, 1996 |