Z-1443-2020Class II

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

Name: Z-1443-2020 RespVent Closed Suction System T-Piece Tracheostomy Adult, Diameter: 4.6mm (14F), Length: 30.5cm (12in.), MDI...
Creator: Respiratory Therapeutics Group Llc
Published: 2019-08-19
License: https://open.fda.gov/license/

Respiratory Therapeutics Group LLC / initiated 2019-08-19 / Open, Classified

FDA source

RESPIRATORY THERAPEUTICS GROUP LLC began a recall of RespVent Closed Suction System T-Piece Tracheostomy Adult, Diameter: 4.6mm (14F), Length: 30.5cm (12in.), MDI Adapter, Cont. 10 Closed Suction Catheter... on 2019-08-19. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1443-2020
Classification: Class II
Status: Open, Classified
Initiated: 2019-08-19
Posted: 2020-03-05
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.
Product code: BSY Catheters, Suction, Tracheobronchial
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.
FDA 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 in commerce: 723 cases (7230 units)
Distribution: US Nationwide distribution in the states of CA, NJ, NY. OUS: None
Product codes and lots: Lot KS1901013: 20019/03/31 - 06/192019 Lot KS1902002: 2019/06/21 - 07/31/2019

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1443-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1443-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-03-11	2020-03-05

Product code BSY

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)