FDA Device recall Z-0819-2024
Custom procedural convenience kits and trays, cardiac, labeled as: a) CENTRAL LINE INSERTION PACK, kit number LLCE52
- FDA Device
- Class II
- ongoing
- Published 2024-02-07
On 2024-02-07 the FDA classified a Class II recall of Custom procedural convenience kits and trays, cardiac, labeled as: a) CENTRAL LINE INSERTION PACK, kit number LLCE52 by American Contract Systems, citing during an internal investigation, ACS identified that several components were "piggybacked" to ACS trays and subjected to the ACS sterilization process. There is no supporting doc….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0819-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-11-29 |
| Published | 2024-02-07 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | American Contract Systems |
| Distribution | US |
Product
Custom procedural convenience kits and trays, cardiac, labeled as: a) CENTRAL LINE INSERTION PACK, kit number LLCE52; b) Adult Central Line Insertion Supply Kit, kit number UICL44N; c) Pediatric Central Line Insertion, kit number UIPL77K
Reason
During an internal investigation, ACS identified that several components were "piggybacked" to ACS trays and subjected to the ACS sterilization process. There is no supporting documentation stating the "piggybacked" components were assessed to determine if they were suitable for exposure to elevated temperatures for an extended period of time and further exposure to sterilization. As a result, the piggybacked components may (1) have a loss/lack of functionality, (2) loss of drug efficacy, if applicable, and (3) may have had higher than specified EO residuals.
Identifiers
| code_info | a) LLCE52, UDI/DI 00191072030832, Lot Numbers: 912231, exp. 11/30/2023; b) UICL44N, UDI/DI 00191072142696, Lot Number…a) LLCE52, UDI/DI 00191072030832, Lot Numbers: 912231, exp. 11/30/2023; b) UICL44N, UDI/DI 00191072142696, Lot Numbers: 991231, exp. 1/9/2024; 891231, exp. 1/30/2024 c) UIPL77K, UDI/DI 00191072142801, Lot Numbers: 748221, exp. 9/9/2023; 650221, exp. 12/16/2023; 919231, exp. 3/22/2024 |
|---|
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-0819-2024%22
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