FDA Device recall Z-0295-2020
Argon Medical Devices Septishield II, 80 cm, REF 497302, 25/box, Sterile, Rx. The firm name on the label is Argon Medical Devices, Inc., At…
- FDA Device
- Class II
- terminated
- Published 2019-11-13
On 2019-11-13 the FDA classified a Class II recall of Argon Medical Devices Septishield II, 80 cm, REF 497302, 25/box, Sterile, Rx. The firm name on the label is Argon Medical Devices, Inc., At… by Argon Medical Devices, citing the seal formed on the edge of the pouch may be incomplete, which could result in a loss of sterility to the product.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0295-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-10-16 |
| Published | 2019-11-13 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Argon Medical Devices |
| Distribution | US |
Product
Argon Medical Devices Septishield II, 80 cm, REF 497302, 25/box, Sterile, Rx. The firm name on the label is Argon Medical Devices, Inc., Athens, TX.
Reason
The seal formed on the edge of the pouch may be incomplete, which could result in a loss of sterility to the product.
Identifiers
| code_info | Lot numbers 11228251 and 11229805 |
|---|
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-0295-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.