The Recall Desk
SevereFDA (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.

What this means for you

Illness, injury, or structural failure has been reported. 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
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 →

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