Class 1 Device Recall Infant Nasal CPAP
|Date Initiated by Firm
||April 15, 2014
|Date Posting Updated
||May 20, 2014
||Terminated 3 on September 30, 2014
|Recall Event ID
||Set, tubing and support, ventilator (w harness) - Product Code BZO
||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.
||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.
| Fisher & Paykel Healthcare, Ltd.
15 Maurice Paykel Place
Auckland New Zealand
|For Additional Information Contact
949-453-4000 Ext. 1423
|The Infant Nasal CPAP Prong has the potential to detach from the Nasal Tubing and therapy is likely to be interrupted.
||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)
||Worldwide Distribution - USA (nationwide) and Internationally to:
TRINIDAD & TOBAGO
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.