Blue Rhino G2 Tracheostomy Introducer Sets Recalled for Unsecure Connections
Cook Incorporated is recalling Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Sets due to unsecure connections with 15mm caps and circuit components that may disconnect during medical procedures.
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: This is an FDA Class I recall. FDA Class I recalls are subject to a minimum severity threshold of Severe (4) per the classification rules. No deaths or injuries have been reported in the source material.
Plain-English summary
Cook Incorporated is recalling Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Sets. These medical devices are used in tracheostomy procedures.
The recalled devices are not making secure connections with 15mm caps and other 15mm circuit components and accessories. This results in unsecure connections between the device connector and circuit components, which could disconnect during use.
The affected devices have been distributed worldwide, including throughout the United States. Approximately 3,053 units are involved in this recall.
The recalled product
- 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)
- Manufacturer
- Cook Incorporated
- Hazard
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-PTIS-100-HC-G-EU-FLEX7.5 (G57695): UDI-DI 00827002576957
- Lot Number 14842940
- C-PTIS-100-HC-G-EU-FLEX8.5 (G57696): UDI-DI 00827002576964
- Lot Numbers 14727192
- 14332964
- 14335896
- 14380758
- 14380755
- 14332978
- 14332973
- 14335892
- 14335893
- 14464000
- 14332985
- 14464008
- 14463988
- 14503228
- 14503224
- 14503222
- 14503229
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.
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