Fisher & Paykel Healthcare Recalls Reusable Breathing Circuits Due to Hole Damage
Fisher & Paykel Healthcare is recalling specific lots of reusable breathing circuits because tube hole damage could cause gas leaks and loss of pressure during oxygen therapy.
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: The agency classified this recall as Class I — 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. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "FPH has become aware that one batch of tubes supplied to FPH may contain hole damage. These tubes were incorporated by FPH into certain 900MR068 reusable circuits with lot numbers 110810 and 111020. If this hole damage is not detected…"
Plain-English summary
Fisher & Paykel Healthcare, Ltd. is recalling certain lots of reusable breathing circuits. The affected products are non-heated breathing circuits, 1.8m or 6 feet in length, used as an oxygen therapy delivery system for adult patients. The specific lot numbers involved are 110810 and 111020.
The recall was initiated because the manufacturer became aware that one batch of tubes supplied to them may contain hole damage. These tubes were incorporated into the 900MR068 reusable circuits. If this hole damage is not detected during the standard leak test before patient use, it could potentially result in a gas leak in the breathing system. This may lead to a loss of pressure for the intubated patient.
A total of 200 units were distributed worldwide, with 26 units distributed in the United States. The US distribution included Illinois, Indiana, Arkansas, and Georgia. The source text does not specify further instructions for consumers or healthcare providers regarding the immediate handling of these devices.
The recalled product
- Product
- Fisher & Paykel Healthcare reusable breathing circuit. Non-heated breathing circuit, 1.8m or 6 feet in length. Oxygen therapy delivery system for adult patient.
- Manufacturer
- Fisher & Paykel Healthcare, Ltd.
- 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 (1)
- Lots 110810 and 111020
Distribution
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