FDAClass IIMarch 11, 2020

RespVent Closed Suction System T-Piece Tracheostomy recall

RespVent Closed Suction System T-Piece Tracheostomy Adult, Diameter: 4.6mm (14F), Length: 30.5cm (12in.), MDI Adapter, Cont. 10 Closed Suction…

Why was RespVent Closed Suction System T-Piece Tracheostomy 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.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot KS1901013: 20019/03/31 - 06/192019 Lot KS1902002: 2019/06/21 - 07/31/2019

Product
RespVent Closed Suction System T-Piece Tracheostomy Adult, Diameter: 4.6mm (14F), Length: 30.5cm (12in.), MDI Adapter, Cont. 10 Closed Suction…
Recalling firm
RESPIRATORY THERAPEUTICS GROUP LLC
Quantity
723 cases (7230 units)
Distribution
US Nationwide distribution in the states of CA, NJ, NY. OUS: None
Recall date
March 11, 2020
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls