Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set — Class I medical device recall Z-1427-2023
Ongoing recall by Cook Incorporated, reported 2023-05-17, distributed nationwide. There were reports from customers that the tracheostomy in the sets and trays is not making a secure connectio
| Recall number | Z-1427-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cook Incorporated, Bloomington, IN, United States |
| Recall initiated | 2023-04-07 |
| Classified | 2023-05-10 |
| Reported by FDA | 2023-05-17 |
| Distributed | Nationwide (US) |
| Quantity | 3.053 units |
| UPC / GTIN / UDI-DI | 00827002576919, 00827002576926, 00827002576957, 00827002576964 |
| Lot numbers | 14163328, 14204927, 14221125, 14221180, 14221190, 14221198, 14227740, 14227743, 14250265, 14250269, 14264399, 14299799, 14299802, 14299803, 14317213, 14317245, 14332964, 14332973, 14332978, 14332985, 14335892, 14335893, 14335896, 14345587, 14345634, 14345667, 14345687, 14365693, 14365694, 14365696, 14365699, 14365701, 14376893, 14380755, 14380758, 14407846, 14456431, 14456438, 14456443, 14463988 and 46 more |
| Model numbers | C-PTIS-100-HC-G-EU-FLEX7.5 |
Product
Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set, Reference Part Numbers C-PTIS-100-HC-G-EU-FLEX7.5 (G57695), C-PTIS-100-HC-G-EU-FLEX8.5 (G57696), C-PTIS-100-HC-G-NA-FLEX7.5 (G57691), C-PTIS-100-HC-G-NA-FLEX8.5 (G57692)
Reason for recall
There were reports from customers that the tracheostomy in the sets and trays is not making a secure connection with the 15mm cap and other 15mm circuit components and accessories. This resulted in an unsecure connection between the device connector and circuit components, cap, or accessories.
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-1427-2023. 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.