Reported Mar 11, 2020 · Ongoing
RespVent Closed Suction System T-Piece Tracheostomy Adult, Diameter: 4.6mm (14F), Length: 30.5cm (12in.), MDI Adapter,…
Respiratory Therapeutics Group LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: RESPIRATORY THERAPEUTICS GROUP LLC · 5670 Wilshire Blvd Ste 1803 · Los Angeles, CA · 90036-5679
Is this the product you have?
- RespVent Closed Suction System T-Piece Tracheostomy Adult
- Diameter4.6mm (14F)
- Length30.5cm (12in.), MDI Adapter, Cont. 10 Closed Suction Catheter, Sterile R, RxOnly
- Reorder NumberRTG-02300
- UDI00850108006035 -
- Product UsageTo be used to aspirate liquids or semi solids from a patient s upper airway
- Lot codes and dates
- Lot KS190101320019/03/31 - 06/192019
- Lot KS19020022019/06/21 - 07/31/2019
- Amount recalled
- 723 cases (7230 units)
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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