The Recall Desk
HighFDA (Devices)·Z-1443-2020·Announced 2020-03-11

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.

What this means for you

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 solid
Manufacturer
RESPIRATORY THERAPEUTICS GROUP LLC
Category
Medical Device — Respiratory / Suction
Hazard

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

Distributed nationwide across the United States.

The notice also names 3 states specifically:

Related recalls

Same hazard · device disconnection

See all →