FDA Device recall Z-2465-2025
AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) LAP CHOLE PACK, Model/Item Number CILC69L
- FDA Device
- Class II
- ongoing
- Published 2025-09-03
On 2025-09-03 the FDA classified a Class II recall of AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) LAP CHOLE PACK, Model/Item Number CILC69L by American Contract Systems, citing during an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some components are not fit for furthe….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2465-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-07-14 |
| Published | 2025-09-03 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | American Contract Systems |
| Distribution | IL, LA |
Product
AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) LAP CHOLE PACK, Model/Item Number CILC69L; 2) LAP CHOLE PACK, Model/Item Number HNLC80J; 3) LAP CHOLE PACK, Model/Item Number JKLC55H; 4) LAPAROSCOPY PACK, Model/Item Number LLLA21K; 5) GENERAL LAPAROSCOPY MPH, Model/Item Number MPGL15G;
Reason
During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some components are not fit for further sterilization according to ACS procedures. As a result, ACS is unable to confirm product sterilization assurance requirements were met.
Identifiers
| code_info | 1) Model/Item Number CILC69L: UDI/DI 00191072235503, Kit Lot Numbers: 42-7937111, 42-8049311; 2) Model/Item Number H…1) Model/Item Number CILC69L: UDI/DI 00191072235503, Kit Lot Numbers: 42-7937111, 42-8049311; 2) Model/Item Number HNLC80J: UDI/DI 00191072193650, Kit Lot Numbers: 42-8044511, 42-8118911, 42-7977011, 42-7803211; 3) Model/Item Number JKLC55H: UDI/DI 00191072235138, Kit Lot Numbers: 42-7814311; 4) Model/Item Number LLLA21K: UDI/DI 00191072233486, Kit Lot Numbers: 70-052582, 70-053048, 70-051564, 70-051373, 70-051163, 70-053446, 70-053776; 5) Model/Item Number MPGL15G: UDI/DI 00191072223197, Kit Lot Numbers: 5436916, 5436615 |
|---|
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-2465-2025%22
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