[Recalled] Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray, Reference Part Numbers C-PTISYJ-100-HC-G-EU-FLEX8.5 (G57725), C-PTISYJ-100-HC-G-NA-FLEX7.5 (G57720), C-PTISYJ-100-HC-G-NA-FLEX8.5 (G57721), C-PTISY-100-HC-G-NA-FLEX8.
Authorities recorded a safety problem with this product. The details below come directly from the government recall notice.
Recall details
| Product | Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray, Reference Part Numbers C-PTISYJ-100-HC-G-EU-FLEX8.5 (G57725), C-PTISYJ-100-HC-G-NA-FLEX7.5 (G57720), C-PTISYJ-100-HC-G-NA-FLEX8.5 (G57721), C-PTISY-100-HC-G-NA-FLEX8.5 (G57717), C-PTISY-100-HC-G-NA-FLEX7.5 (G57716) |
|---|---|
| Brand / manufacturer | Cook Incorporated |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-1428-2023 |
| Country of notice | United States |
| Risk level | Class I |
| Hazard type | recall |
| Notice date | 07 April 2023 |
| EAN / barcode | 00827002577251 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: 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.
This Class I recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Stop using the product immediately and follow the authority's remedy (return, repair, or disposal).
Read the full official notice →
Related recalls from Cook Incorporated
This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.
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