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Open, Classified

Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080060

FDA Recall Z-1959-2023 · Posted 2023-06-29

Recalling FirmTELEFLEX LLC
Recall StatusOpen, Classified
Product CodeBTR
Date Initiated2023-05-25
Product Quantity4160 units

Reason for Recall

Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.

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: [email protected]

Root Cause

Under Investigation by firm

Distribution Pattern

US Nationwide distribution including Puerto Rico.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K961837RUSH ORAL/NASAL TRACHEAL TUBE CUFFED MAGILL/MURPHYRusch Intl. · 1996-08-16

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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