FDA Device recall Z-1445-2024
Centurion manual surgical kits labeled as: a) SUTURE REMOVAL TRAY, Product Code TRI55405
- 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) SUTURE REMOVAL TRAY, Product Code TRI55405 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-1445-2024 |
| 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) SUTURE REMOVAL TRAY, Product Code TRI55405; b) SUTURE REMOVAL SET, Product Code 60265 MEDLINE manual surgical kits labeled as: a) SUTURE REMOVAL TRAY, Product Code 60280; b) SUTURE REMOVAL TRAY, Product Code 86125; c) SUTURE REMOVAL KIT, Product Code SR60555; d) SKIN STAPLE REMOVER, Product Code TRI44105
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) TRI55405, UDI/DI 20193489112709 (case) 10193489112702 (each), Lot Numbers: 2023022390 b) 60265, UDI/DI 50653160090…a) TRI55405, UDI/DI 20193489112709 (case) 10193489112702 (each), Lot Numbers: 2023022390 b) 60265, UDI/DI 50653160090982 (case) 00653160090987 (each), Lot Numbers: 2023041190 MEDLINE: a) 60280, UDI/DI 20193489111948 I(case) 10193489111941 (each), Lot Numbers: 2023031790, 2023070590, 2023112790; b) 86125, UDI/DI 20193489111832 (case) 10193489111835 (each), Lot Numbers: 2023032090, 2023120490; c) SR60555, UDI/DI 20193489111955 (case) 10193489111958 (each), Lot Numbers: 2023111590; d) TRI44105, UDI/DI 20193489112730 (case) 10193489112733 (each), Lot Numbers: 2023072490 |
|---|
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-1445-2024%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.