RespVent Closed Suction System Tracheostomy T-Piece Recall for Connection Defect
Respiratory Therapeutics Group is recalling RespVent Closed Suction System T-Pieces because catheters may not be tightly connected to the thumb port, potentially reducing suction performance.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device defect that could make it difficult to remove a catheter from a patient's trachea, representing a risk of harm where injury has not yet been reported, consistent with the 'High' severity criteria.
Plain-English summary
Respiratory Therapeutics Group LLC is recalling 723 cases (7,230 units) of 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. The affected units are identified by Lot KS1901013 (manufactured 2019/03/31 - 06/19/2019) and Lot KS1902002 (manufactured 2019/06/21 - 07/31/2019).
The recall was initiated because it was determined that some units of catheters were not tightly connected to the thumb port. This defect may result in the catheter disconnecting from the thumb port, which could reduce suction performance and make it difficult to remove the catheter from the patient's trachea.
The affected products were distributed nationwide in the United States, specifically in the states of California, New Jersey, and New York. No international distribution is reported. Healthcare providers and facilities should stop using the affected units and contact the manufacturer for further instructions.
The recalled product
- Product
- 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…
- Manufacturer
- RESPIRATORY THERAPEUTICS GROUP LLC
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot KS1901013: 20019/03/31 - 06/192019 Lot KS1902002: 2019/06/21 - 07/31/2019
Distribution
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