Recall Z-1539-2014 ยท BZO Set, Tubing And Support, Ventilator (W Harness)
Fisher & Paykel Healthcare, Ltd.
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.
| Date | May 20, 2014 (initiated Apr 15, 2014) |
| Status | Terminated |
| Reason | The Infant Nasal CPAP Prong has the potential to detach from the Nasal Tubing and therapy is likely to be interrupted. |
| Root cause | Device Design |
| Action | 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. |
| Quantity | 62,063 units total (14,420 units USA) |
| 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 RWAND |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.