RespVent Closed Suction System T-Piece Tracheostomy Adult — Class II medical device recall Z-1443-2020
Ongoing recall by RESPIRATORY THERAPEUTICS GROUP LLC, reported 2020-03-11, distributed nationwide. It has been determined that some units of catheters were not tightly connected to the thumb port. This may res
| Recall number | Z-1443-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | RESPIRATORY THERAPEUTICS GROUP LLC, Los Angeles, CA, United States |
| Recall initiated | 2019-08-19 |
| Classified | 2020-03-05 |
| Reported by FDA | 2020-03-11 |
| Distributed | Nationwide (US) |
| UPC / GTIN / UDI-DI | 00850108006035 |
| Lot numbers | 06/192019, 20019/03/31, 2019/06/21, KS1901013, KS1902002 |
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1443-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.