Reported May 28, 2014 · Terminated
Infant Nasal CPAP (continuous positive airway pressure) Prong, Nasal. CPAP Prongs (10 pack): Model No. BC3020-10,…
Fisher & Paykel Healthcare, Ltd.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Fisher & Paykel Healthcare, Ltd. · 15 Maurice Paykel Place · Auckland, N/A · N/A
Is this the product you have?
- Infant Nasal CPAP (continuous positive airway pressure) Prong, Nasal
- CPAP Prongs (10 pack)
Model No. BC3020-10BC3520-10BC4030-10BC4540-10BC5040-10BC5050-10BC5550-10BC5560-10BC6060-10BC6070-10BC6570-10
- Bubble CPAP Starter KitsModel No. BC461-SK, BC471-SK, BC490-SK, BC491-SK, BC492-SK. The Nasal CPAP Prongs connect to the FPH FlexiTrunk Patient Interface
- Lot codes and dates
- Nasal CPAP Prongs (10 pack), Lot Numbers 13060603XX through 14032503XX; 13082003XX through 14032503XX; 13091903XX through 14032503XX; 13082603XX through 14032503XX; 13091903XX through 14032503XX; 14022603XX through 14032503XX; 14022603XX through 14032503XX; 14031203XX through 14032503XX; 14031203XX through 14032503XX; 14031203XX through 14032503XX; 14031203XX through 14032503XX. Bubble CPAP Starter Kits, Lot Numbers 131007 through 140325.
- Amount recalled
- 62,063 units total (14,420 units USA)
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
The Infant Nasal CPAP Prong has the potential to detach from the Nasal Tubing and therapy is likely to be interrupted.
Using this product could cause serious injury, illness or death — stop using it now.
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