Infant Nasal CPAP — Class I medical device recall Z-1539-2014
Terminated recall by Fisher & Paykel Healthcare, Ltd., reported 2014-05-28, distributed nationwide. The Infant Nasal CPAP Prong has the potential to detach from the Nasal Tubing and therapy is likely to be inte
| Recall number | Z-1539-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Fisher & Paykel Healthcare, Ltd., Auckland, N/A, New Zealand |
| Recall initiated | 2014-04-15 |
| Classified | 2014-05-20 |
| Reported by FDA | 2014-05-28 |
| Terminated | 2014-09-30 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AU, BD, BE, CA, CH, CL, CN, DE, ES, FR, GB, GR, HU, ID, IL, IN, IQ, IT, JP, LK, MY, NL, NP, NZ, PE, PL, PT, QA, RO, RU, SA, TH, TR, TT, TW, ZA |
| Reason classes | device malfunction |
| Lot numbers | 13060603XX, 131007 |
| Model numbers | BC3020-10, BC3520-10, BC4030-10, BC4540-10, BC461-SK, BC471-SK, BC490-SK, BC491-SK, BC492-SK, BC5040-10, BC5050-10, BC5550-10, BC5560-10, BC6060-10, BC6070-10, BC6570-10 |
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.
Reason for recall
The Infant Nasal CPAP Prong has the potential to detach from the Nasal Tubing and therapy is likely to be interrupted.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1539-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.