Fisher & Paykel Recalls Infant Nasal CPAP Prongs for Detachment Risk
Fisher & Paykel Healthcare is recalling infant nasal CPAP prongs and starter kits because the prongs may detach from the tubing, interrupting therapy.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The source text explicitly states the agency classification is Class I, which mandates a severity score of 5 per the rubric.
Plain-English summary
Fisher & Paykel Healthcare, Ltd. is recalling Infant Nasal CPAP Prongs and Bubble CPAP Starter Kits. The affected products include CPAP Prongs (10 pack) with model numbers BC3020-10 through BC6570-10, and Bubble CPAP Starter Kits with model numbers BC461-SK through BC492-SK. The Nasal CPAP Prongs connect to the FPH FlexiTrunk Patient Interface.
The recall is being conducted because the Infant Nasal CPAP Prong has the potential to detach from the Nasal Tubing, which is likely to interrupt therapy. The agency has classified this recall as Class I.
A total of 62,063 units were distributed, with 14,420 units distributed in the United States. The products were distributed nationwide in the US and internationally to numerous countries including Argentina, Australia, Canada, and the United Kingdom. Consumers should stop using the affected products and contact the manufacturer for instructions.
The recalled product
- Product
- Infant Nasal CPAP (continuous positive airway pressure) Prong, Nasal. CPAP Prongs (10 pack): Model No. BC3020-10, BC3520-10, BC4030-10, BC4540-10, BC5040-10, BC5050-10, BC5550-10, BC5560-10, BC6060-10, BC6070-10, BC6570-10. Bubble CPAP Starter Kits: Model No. BC461-SK, BC
- Manufacturer
- Fisher & Paykel Healthcare, Ltd.
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 (9)
- Nasal CPAP Prongs (10 pack)
- Lot Numbers 13060603XX through 14032503XX
- 13082003XX through 14032503XX
- 13091903XX through 14032503XX
- 13082603XX through 14032503XX
- 14022603XX through 14032503XX
- 14031203XX through 14032503XX
- 14031203XX through 14032503XX. Bubble CPAP Starter Kits
- Lot Numbers 131007 through 140325.
Distribution
Distributed nationwide across the United States.
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