FDA Device recall Z-0637-2024
High Frequency Transport Phasitron Breathing Circuit Kit REF: A50605-D, Rx Only, CE 0123
- FDA Device
- Class I
- ongoing
- Published 2024-01-24
On 2024-01-24 the FDA classified a Class I recall of High Frequency Transport Phasitron Breathing Circuit Kit REF: A50605-D, Rx Only, CE 0123 by Percussionaire, citing due to an assembly error within the breathing circuit, their pressure output of the breathing circuit kit can be affected and have severe impact to the end user.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0637-2024 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2023-12-12 |
| Published | 2024-01-24 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Percussionaire |
| Distribution | AL, AR, CA, CT, FL, GA, IL, IN, KS, LA, MI, MN, MO, NC, NJ, OH, OR, TN, TX, UT, VA |
Product
High Frequency Transport Phasitron Breathing Circuit Kit REF: A50605-D, Rx Only, CE 0123
Reason
Due to an assembly error within the breathing circuit, their pressure output of the breathing circuit kit can be affected and have severe impact to the end user
Identifiers
| code_info | UDI: (01)10849436000331/Lot # WO05216, WO05254, WO05321, WO05392, WO05559, WO05588, WO05684, WO05749, WO05896, WO05930,WO06028 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0637-2024%22
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