Recall Z-1539-2014— Fisher & Paykel Healthcare, Ltd.
Class I · Terminated
Class I FDA medical device recall by Fisher & Paykel Healthcare, Ltd., initiated 2014-04-15, terminated 2014-09-30. FDA's recall record names no specific 510(k) clearance for this event. 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, BC471-SK, BC490-SK, BC491-SK, BC492-SK. The Nasal CPAP Prongs connect to the FPH FlexiTrunk Patient Interface.. Reason: The Infant Nasal CPAP Prong has the potential to detach from the Nasal Tubing and therapy is likely to be interrupted..
- Recalling firm
- Fisher & Paykel Healthcare, Ltd.
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2014-04-15
- Terminated
- 2014-09-30
- Firm location
- Auckland, N/A, New Zealand
Product description
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, BC471-SK, BC490-SK, BC491-SK, BC492-SK. The Nasal CPAP Prongs connect to the FPH FlexiTrunk Patient Interface.
Reason for recall
The Infant Nasal CPAP Prong has the potential to detach from the Nasal Tubing and therapy is likely to be interrupted.
Data sourced from openFDA. This site is unofficial and independent of the FDA.