Infant Nasal CPAP (continuous positive airway pressure) Prong, Nasal. CPAP Prongs (10 pack): Model No. BC3020-10, BC3520

FDA device recall Z-1539-2014 · posted 2014-05-20 · Terminated

Recall details

Recalling firm

Fisher & Paykel Healthcare, Ltd.

Reason for recall

The Infant Nasal CPAP Prong has the potential to detach from the Nasal Tubing and therapy is likely to be interrupted.

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.

Root cause

Device Design

Status

Terminated

Product code

BZO

Quantity affected

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 ITAL

Date initiated

2014-04-15

Date posted

2014-05-20

Date terminated

2014-09-30

Location

Auckland, East Tamaki, New Zealand