FDA Device recall Z-1443-2024
Centurion manual surgical kits labeled as: a) STERILE ALLIS TISS FCP 10", Product Code I68905
- FDA Device
- Class II
- ongoing
- Published 2024-04-10
On 2024-04-10 the FDA classified a Class II recall of Centurion manual surgical kits labeled as: a) STERILE ALLIS TISS FCP 10", Product Code I68905 by Medline Industries Northfield, citing product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1443-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-02-23 |
| Published | 2024-04-10 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Medline Industries Northfield |
| Distribution | US |
Product
Centurion manual surgical kits labeled as: a) STERILE ALLIS TISS FCP 10", Product Code I68905; b) VAGINAL REPAIR KIT, Product Code MNS11505; c) PTCA ADD-ON KIT, Product Code MNS11545; d) INSTRUMENT SET, Product Code SUT21355
Reason
Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.
Identifiers
| code_info | a) I68905, UDI/DI 00653160350944 (case) 10653160350941 (each), Lot Numbers: 2023012590, 2023042590; b) MNS11505, UDI…a) I68905, UDI/DI 00653160350944 (case) 10653160350941 (each), Lot Numbers: 2023012590, 2023042590; b) MNS11505, UDI/DI 00653160320213 (case) 10653160320210 (each), Lot Numbers: 2023022490, 2023071390; c) MNS11545, UDI/DI 00653160320305 (case) 10653160320302 (each), Lot Numbers: 2023021390; d) SUT21355, UDI/DI 00653160329223 (case) 10653160329220 (each), Lot Numbers: 2023060790 |
|---|
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-1443-2024%22
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