Custom procedural convenience kits and trays — Class II medical device recall Z-0822-2024
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-0822-2024 |
|---|---|
| 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 | 3,196 units |
| UPC / GTIN / UDI-DI | 00191072126061, 00191072128904, 00191072141156, 00191072144034, 00191072146267, 00191072169075, 00191072171351, 00191072188465, 00191072188830 |
| Lot numbers | 638221, 645221, 646221, 647221, 654221, 658221, 660221, 661221, 666221, 675221, 679221, 682221, 687221, 689221, 694221, 698221, 700221, 710221, 720221, 721221, 735221, 744221, 752221, 756221, 766221, 768221, 790221, 792221, 793221, 797221, 804221, 839221, 840221, 845221, 853221, 856221, 879231, 882231, 888221, 891221 and 24 more |
| Expiration dates | 2023-04-19, 2023-04-22, 2023-05-21, 2023-05-24, 2023-05-27, 2023-05-31, 2023-06-04, 2023-06-09, 2023-06-10, 2023-07-15, 2023-07-22, 2023-07-26, 2023-07-27, 2023-07-29, 2023-08-20, 2023-08-22, 2023-08-31, 2023-09-01, 2023-09-05, 2023-09-13, 2023-09-22, 2023-10-06, 2023-10-07, 2023-10-17, 2023-10-27 and 40 more |
Product
Custom procedural convenience kits and trays, gastroenterological & urological, labeled as: a) LAP KIDNEY MODULE, kit number AGKD50L; b) ROBOTIC PROSTATE PACK - 264852, kit number ANPR34S; c) LAP CHOLE - 213388, kit number BFLC02AD; d) GENERAL LAPAROSCOPY PACK, kit number GUGE09I; e) LAP CHOLE PACK, kit number HNLC80I; f) Lap Chole Ovarian Appy, kit number JSLC06I; g) LAP CHOLE, ST LUKES, kit number LMLP08Z; h) ROBOTIC PACK - 242561, kit number MHRB88AJ; i) KIT, GENERAL LAPAROSCOPY, kit number MMLP40F; j) KIT, MAJOR LAPAROTOMY, kit number MMML26F; k) LAP CHOLE - LAP HERNIA PACK - 282807, kit number OWLC07K; l) GENERAL LAPAROSCOPY SAH, kit number SAGL57H; m) ROBOTIC PACK SAH, kit number SARB30K; n) ROBOTIC PACK SAH, kit number SARB30L; o) ROBOTIC PACK SAH, kit number SARB30M; p) LAP CHOLE PACK, kit number SMLC53; q) ROBOTICS PACK, kit number SNRP85D; r) ROBOTIC PACK, kit number SSRO22C; s) ROBOTIC PACK, kit number SSRO22D; t) TPK DAVINCI PROSTATE SYSTEM, kit number TPDV16; u) ASC LAP CHOLE PACK (PS 42279), kit number UICH53Y; v) GENERAL LAPAROSCOPIC PACK, kit number WVGL60E
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-0822-2024. 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.