CLASS II ONGOING Device recall · Reported 11 Mar 2020 · FDA Enforcement Report
RespVent Closed Suction System T-Piece Tracheostomy Adult recalled
Respiratory Therapeutics Group is recalling RespVent Closed Suction System T-Piece Tracheostomy Adult, Diameter: (14F), Length:, MDI, distributed nationwide in the US. The recall was initiated on 19 Aug 2019 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1443-2020
- FDA event ID
- 84859
- Recalling firm
- Respiratory Therapeutics Group, Los Angeles, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 19 Aug 2019
- FDA classified
- 5 Mar 2020
- Reported
- 11 Mar 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Sterility
- Device type
- Heart & Vascular Devices
Timeline
| 19 Aug 2019 | Recall initiated by company | |
| 5 Mar 2020 | Classified by FDA | +199 days |
| 11 Mar 2020 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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 upper airway.
Where it was distributed
US Nationwide distribution in the states of CA, NJ, NY. OUS: None
Questions about this recall
Is RespVent Closed Suction System T-Piece Tracheostomy Adult, Diameter: (14F), Length:, MDI recalled?
Yes. Respiratory Therapeutics Group recalled RespVent Closed Suction System T-Piece Tracheostomy Adult, Diameter: (14F), Length:, MDI on 19 Aug 2019. The recall is Class II and its status is Ongoing. Recall number Z-1443-2020.
Why was it 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.
Which lots are affected?
Lot KS1901013: 20019/03/31 - 06/192019 Lot KS1902002: 2019/06/21 - 07/31/2019
Where was it sold?
US Nationwide distribution in the states of CA, NJ, NY. OUS: None
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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