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U.S. Department of Health and Human Services

Class 1 Device Recall Infant Nasal CPAP

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  Class 1 Device Recall Infant Nasal CPAP see related information
Date Initiated by Firm April 15, 2014
Date Posted May 20, 2014
Recall Status1 Terminated 3 on September 30, 2014
Recall Number Z-1539-2014
Recall Event ID 68011
Product Classification Set, tubing and support, ventilator (w harness) - Product Code BZO
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.
Code Information 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.
Recalling Firm/
Manufacturer		 Fisher & Paykel Healthcare, Ltd.
15 Maurice Paykel Place
East Tamaki
Auckland New Zealand
For Additional Information Contact Raymond Yan
949-453-4000 Ext. 1423
Manufacturer Reason
for Recall		 The Infant Nasal CPAP Prong has the potential to detach from the Nasal Tubing and therapy is likely to be interrupted.
FDA Determined
Cause 2		 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 in Commerce 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 RWANDA SAUDI ARABIA SOUTH AFRICA SPAIN SRI LANKA SWITZERLAND TAIWAN THAILAND TRINIDAD & TOBAGO TURKEY UNITED ARAB EMIRATES
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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