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.
- Recall Initiated
- April 15, 2014
- Posted
- May 20, 2014
- Terminated
- September 30, 2014
- Recall Number
- Z-1539-2014
- Quantity
- 62,063 units total (14,420 units USA)
Reason for Recall
The Infant Nasal CPAP Prong has the potential to detach from the Nasal Tubing and therapy is likely to be interrupted.
Distribution
Worldwide Distribution - USA (nationwide) and Internationally to: ARGENTINA AUSTRALIA BANGLADESH BELGIUM CANADA CHILE CHINA FRANCE GERMANY GREAT BRITAIN GREECE HUNGARY INDIA INDONESIA IRAQ ISRAEL ITALY JAPAN LIBYA MALAYSIA NEPAL NETHERLANDS NEW ZEALAND PERU POLAND PORTUGAL QATAR ROMANIA RUSSIA RWANDA SAUDI ARABIA SOUTH AFRICA SPAIN SRI LANKA SWITZERLAND TAIWAN THAILAND TRINIDAD & TOBAGO TURKEY UNITED ARAB EMIRATES
Lot / Code Info
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.
Root Cause
Device Design
Action Taken
Fisher & Paykel Healthcare sent an Urgent Medical Device Recall letter on April 11, 2014, to all affected customers. The letter informed them of the problems identified and the actions to be taken. Customers were instructed to complete Section A 'Inspection of Stock' on the Urgent Medical Device Recall Response Form and return it to their FPH Representative. Destroy the Affected Prongs by cutting them in half. Customers were also instructed to contact their FRH Representative for replacement product. For questions regarding this recall call 949-453-4000, ext 1423.