Device recall: Infant Nasal CPAP (continuous positive airway pressure) Prong, Nasal. CPAP Prongs (10 pack): Model No. BC3020-10…
Class I FDA enforcement event 68011. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
The Infant Nasal CPAP Prong has the potential to detach from the Nasal Tubing and therapy is likely to be interrupted.
Class I, in the words of FDA
a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death
Fisher & Paykel Healthcare, Ltd. started this device recall on 15 Apr 2014. The firm address in the FDA record is in Auckland. FDA put the recall in Class I. FDA event 68011 has 1 product record. The first FDA enforcement report date is 28 May 2014. The record gives the status Terminated, with the termination date 30 Sep 2014.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Worldwide Distribution - USA (nationwide) and Internationally to: ARGENTINA AUSTRALIA BANGLADESH BELGIUM CANADA CHILE CHINA FRANCE GERMANY GREAT BRITAIN GREECE HUNGARY INDIA INDONESIA IRAQ ISRAEL…
Recalling firm
Fisher & Paykel Healthcare, Ltd., Auckland, N/A, New Zealand.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
1 product record in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1539-2014 | 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… | 62,063 units total (14,420 units USA) | Class I | Terminated | 28 May 2014 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class I: The highest of the three FDA recall classes.
The event in context
- Device events that started in 2014
- 1,176
- Share of these events in Class I
- 5%
- Product records in this event
- 1Median of the firm: 1
- Events of the firm on the register
- 7
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 18 Sep 2025 | Airvo 2, REF: PT101US, and myAirvo 2, REF: PT100US, used with Disinfection Kit User Manual, REF: UI-185043723 | Device | Class II | 1 |
| 7 Aug 2024 | PT301US Airvo 3 Respiratory Support Device with software version 1.2.0 and/or 1.5.1 The Airvo 3 is intended to provide h | Device | Class II | 1 |
| 2 Apr 2024 | Airvo 2 Humidifier, REF: PT101US, and myAirvo 2 Humidifier, REF: PT100US | Device | Class II | 1 |
| 6 Nov 2014 | Fisher and Paykel Healthcare (FPH) IW900-Series Infant Warmer Fisher and Paykel; Healthcare CosyCot and Kit Replacement | Device | Class II | 1 |
| 22 Apr 2013 | Fisher & Paykel Healthcare ICON CPAP (continuous positive airway pressure). Models: ICON Auto: ICONAAN, ICONAAN-HT, ICON | Device | Class II | 1 |
| 19 Nov 2012 | Fisher & Paykel Healthcare reusable breathing circuit. Non-heated breathing circuit, 1.8m or 6 feet in length. Oxygen th | Device | Class I | 1 |
Official channels
- FDA enforcement report Z-1539-2014The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
Follow by RSS:Food, drug and device recallsFDA Class I recalls
Cite this page
Recall Register. FDA enforcement event 68011. https://recallregister.com/fda/i/68011/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this 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…
- What quantity of product is in FDA event 68011?
- The FDA record gives this quantity:
62,063 units total (14,420 units USA)
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2014 have the same class?
- 5% of the 1,176 device events that started in 2014 are in Class I.