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Terminated

RUSCH Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF numbers: a) 504550 b) 504555 c) 504560 d) 504565 e) 504570 f) 504575 g) 504580 f) 504585 g) 504590

FDA Recall Z-2320-2021 · Posted None

Recalling FirmTeleflex Medical Europe Ltd
Recall StatusTerminated
Product CodeBTR
Date Initiated2021-07-16
Date Terminated2026-07-24
Product Quantity155030 units

Reason for Recall

The firm received reports that the endotracheal tube cuff could be inflated while the pilot balloon remained flat.

Firm Action

The firm initiated the recall by letter on 07/16/2021. The letter explained the issue and requested the return of the product. Distributors were directed to notify their customers.

Root Cause

Process control

Distribution Pattern

US Nationwide distribution.

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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