FDA Device recall Z-0621-2013
Fisher & Paykel Healthcare reusable breathing circuit
- FDA Device
- Class I
- terminated
- Published 2013-01-09
On 2013-01-09 the FDA classified a Class I recall of Fisher & Paykel Healthcare reusable breathing circuit by Fisher And Paykel Healthcare, citing FPH has become aware that one batch of tubes supplied to FPH may contain hole damage. These tubes were incorporated by FPH into certain 900MR068 reusable circuits with lot numbers….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0621-2013 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2012-11-19 |
| Published | 2013-01-09 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Fisher And Paykel Healthcare |
| Distribution | AR, GA, IL, IN |
Product
Fisher & Paykel Healthcare reusable breathing circuit. Non-heated breathing circuit, 1.8m or 6 feet in length. Oxygen therapy delivery system for adult patient.
Reason
FPH has become aware that one batch of tubes supplied to FPH may contain hole damage. These tubes were incorporated by FPH into certain 900MR068 reusable circuits with lot numbers 110810 and 111020. If this hole damage is not detected during the standard leak test before patient use, it could potentially result in a gas leak in the breathing system, which may lead to a loss of pressure for the int
Identifiers
| code_info | Lots 110810 and 111020 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0621-2013%22
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