Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1443-2020 — 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 u

U.S. FDA — Device Enforcement · United States · 2019-08-19 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1443-2020
Date of alert
2019-08-19
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
RESPIRATORY THERAPEUTICS GROUP LLC
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00850108006035
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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