Agency classClass IOur severity:Severe FDA (Devices)·Z-1428-2023·Announced 2023-05-17

Cook Blue Rhino G2 Tracheostomy Introducer Trays Recalled for Connection Defect

Cook Incorporated is recalling Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Trays because the device connectors are not making secure connections with 15mm caps and other circuit components, resulting in unsecure connections.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: FDA Class I classification mandates a minimum severity score of 4. The recall addresses critical connection defects in surgical tracheostomy equipment that could result in unsecure device connections, regardless of whether specific injuries have been reported.

Plain-English summary

Cook Incorporated is recalling Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Trays due to reported connection defects. The recall affects approximately 25,161 units with five designated part numbers and associated lot numbers, distributed worldwide and in the United States.

Customers reported that the tracheostomy sets and trays are not making secure connections with 15mm caps and other 15mm circuit components and accessories. According to the reports, this results in an unsecure connection between the device connector and circuit components.

Healthcare facilities and medical professionals should stop using affected units and contact Cook Incorporated for information on replacement devices or further guidance. The FDA has classified this as a Class I recall.

The recalled product

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)
Manufacturer: Cook Incorporated
Category: Medical Device — Surgical / Respiratory
Hazard: connection-defect
device-disconnection
Affected units: 25,161

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

C-PTISYJ-100-HC-G-EU-FLEX8.5 (G57725): UDI-DI 00827002577251
Lot Numbers 14351912
14345668
C-PTISYJ-100-HC-G-NA-FLEX7.5 (G57720): UDI-DI 00827002577206
Lot Numbers 14210437
14244442
14227741
14210440
14244446
14227742
14229768
14261042
14270295
14307644
14270297
NS14266221
14327007
14327004
14345700
14351916

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Cook Incorporated under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · Cook Incorporated

See all →

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Severe
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Critical
Cook Centimeter Sizing Catheter recall due to marker band cracking
FDA (Devices) · 2026-05-13
High
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Same hazard · connection defect