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Open, Classified

RespVent Closed Suction System T-Piece Tracheostomy Adult, Diameter: 4.6mm (14F), Length: 30.5cm (12in.), MDI Adapter, Cont. 10 Closed Suction Catheter, Sterile R, RxOnly, Reorder Number: RTG-02300, UDI: 00850108006035 - Product Usage: To be used to aspirate liquids or semi solids from a patient s upper airway.

FDA Recall Z-1443-2020 · Posted None

Recalling FirmRESPIRATORY THERAPEUTICS GROUP LLC
Recall StatusOpen, Classified
Product CodeBSY
Date Initiated2019-08-19
Product Quantity723 cases (7230 units)

Reason for Recall

It has been determined that some units of catheters were not tightly connected to the thumb port. This may result in the catheter disconnecting from the thumb port which could reduce the suction performance and make it difficult to remove from the patient's trachea.

Firm Action

On 8/19/19 a recall notice was sent to all affected customers. The letter outlined the recall issue and requested that customers complete the enclosed form for the return of the products (new and used) and the issuance of replacement product or credit.

Root Cause

Component change control

Distribution Pattern

US Nationwide distribution in the states of CA, NJ, NY. OUS: None

Official Source

View FDA Recall →

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

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