Z-1539-2014Class I

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

Name: Z-1539-2014 Infant Nasal CPAP (continuous positive airway pressure) Prong, Nasal. CPAP Prongs (10 pack): Model No...
Creator: Fisher & Paykel Healthcare, Ltd.
Published: 2014-04-15
License: https://open.fda.gov/license/

Fisher & Paykel Healthcare, Inc. / initiated 2014-04-15 / Terminated / root cause: design

FDA source

Fisher & Paykel Healthcare, Ltd. began a recall of 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... on 2014-04-15. FDA classified it as Class I and gives the reason as "The Infant Nasal CPAP Prong has the potential to detach from the Nasal Tubing and therapy is likely to be interrupted". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1539-2014
Classification: Class I
Status: Terminated
Initiated: 2014-04-15
Posted: 2014-05-20
Terminated: 2014-09-30
Recalling firm: Fisher & Paykel Healthcare, Inc.
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.
Product code: BZO Set, Tubing And Support, Ventilator (W Harness)
Reason for recall: The Infant Nasal CPAP Prong has the potential to detach from the Nasal Tubing and therapy is likely to be interrupted.
Root cause tag: design
FDA 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 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
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1539-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1539-2014	Class I	Terminated	Voluntary: Firm initiated	2014-05-28	2014-05-20

Product code BZO

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)