FDA Medical Device Recalls (openFDA)
RESPIRATORY THERAPEUTICS GROUP LLC: 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.
- Recall number
- Z-1443-2020
- Recalling firm
- RESPIRATORY THERAPEUTICS GROUP LLC
- 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 solids from a patient s upper airway.
- Status
- Open, Classified
- Initiated
- 2019-08-19
- Posted
- not on file
- Terminated
- not on file
- Reason
- 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.
- Root cause
- Component change control
- Action
- On 8/19/19 a recall notice was sent to all affected customers. The letter outlined the recall issue and requested that customers complete the enclosed form for the return of the products (new and used) and the issuance of replacement product or credit.
- Quantity
- 723 cases (7230 units)
- Distribution
- US Nationwide distribution in the states of CA, NJ, NY. OUS: None
- Lot, serial or model codes
- Lot KS1901013: 20019/03/31 - 06/192019 Lot KS1902002: 2019/06/21 - 07/31/2019
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- BSY
- Firm FEI
- 3011285025
- Firm city
- Los Angeles
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28