Flexi-Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 506550
FDA device recall Z-1859-2023 · posted 2023-06-29 · Open, Classified
Recall details
- Recalling firm
- TELEFLEX LLC
- Reason for recall
- Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
- Action taken
- 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
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- BTR
- Quantity affected
- 10600 units
- Distribution
- US Nationwide distribution including Puerto Rico.
- Date initiated
- 2023-05-25
- Date posted
- 2023-06-29
- Location
- Morrisville, NC
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| RUSCH ORAL/NASAL TRACHEAL TUBE, PLAIN MAGILL/MURPHY (K961840) | Rusch Intl. | 1996-06-27 |