FDA Device recall Z-0191-2020
Irrisept Wound Debridement and Cleansing System. 12 units per case
- FDA Device
- Class II
- terminated
- Published 2019-10-30
On 2019-10-30 the FDA classified a Class II recall of Irrisept Wound Debridement and Cleansing System. 12 units per case by Irrimax, citing potential defect in the sterile pouch seal, which may result in a lack of sterility assurance.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0191-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-08-16 |
| Published | 2019-10-30 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Irrimax |
| Distribution | US |
Product
Irrisept Wound Debridement and Cleansing System. 12 units per case.
Reason
Potential defect in the sterile pouch seal, which may result in a lack of sterility assurance.
Identifiers
| code_info | Catalog Number: ISEPT-450-USA; Lot Numbers: 19CAB939, 19DAB431; Expiration Date: 2021-04-30 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0191-2020%22
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