Custom procedural convenience kits and trays — Class II medical device recall Z-0827-2024
Ongoing recall by American Contract Systems, Inc., reported 2024-02-07, distributed nationwide. During an internal investigation, ACS identified that several components were "piggybacked" to ACS trays and s
| Recall number | Z-0827-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | American Contract Systems, Inc., Temple Terrace, FL, United States |
| Recall initiated | 2023-11-29 |
| Classified | 2024-01-26 |
| Reported by FDA | 2024-02-07 |
| Distributed | Nationwide (US) |
| Quantity | 2,717 units |
| UPC / GTIN / UDI-DI | 00191072139184, 00191072162755, 00191072167958, 00191072169341, 00191072170705, 00191072171900, 00191072179326, 00191072179333, 00191072183187, 00191072190031 |
| Lot numbers | 652221, 654221, 658221, 668221, 673221, 686221, 687221, 695221, 700221, 702221, 720221, 728221, 729221, 730221, 744221, 749221, 756221, 757221, 780221, 784221, 795221, 799221, 819221, 838221, 839221, 870221, 876231, 885231, 889221, 900231, 903231, 905231, 911231, 912231, 920231, 921231, 931231, 934231, 939231, 949231 and 10 more |
| Expiration dates | 2023-04-21, 2023-05-10, 2023-06-10, 2023-06-11, 2023-06-30, 2023-07-20, 2023-07-24, 2023-08-04, 2023-08-08, 2023-08-31, 2023-09-01, 2023-09-08, 2023-09-13, 2023-09-27, 2023-09-28, 2023-09-29, 2023-10-07, 2023-10-25, 2023-10-27, 2023-10-30, 2023-11-01, 2023-11-09, 2023-11-10, 2023-11-23, 2023-11-28 and 25 more |
Product
Custom procedural convenience kits and trays, general hospital use, labeled as: a) IR NEURO PACK, kit number AGNE20J; b) ADULT CRANIOTOMY PACK, kit number LLCR99; c) LAMINECTOMY PACK, kit number LLLC26; d) KIT, CRANIOTOMY, kit number MMCR11J; e) KIT, NEURO SPINE, kit number MMNS20H; f) IR NEURO PACK, kit number OSIN77; g) NEURO SAH, kit number SANE32H; h) NEURO SAH, kit number SANE32I; i) S78FCH CRANI PACK (PS 132432), kit number UICR10U; j) CRANI PACK (PS039498), kit number UICR33AW; k) Laminectomy, kit number UILM77AR; l) DIAGNOSTIC NEURO IR TRAY, kit number WENE21D; m) DIAGNOSTIC NEURO IR TRAY, kit number WENE21F; n) DIAGNOSTIC NEURO IR TRAY, kit number WENE21H; o) DIAGNOSTIC NEURO IR TRAY, kit number WENE21H-01; p) NEURO IR TRAY, kit number WENI56F; q) NEURO IR TRAY, kit number WENI56H; r) NEURO IR TRAY, kit number WENI56H-01
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0827-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.