Custom procedural convenience kits and trays — Class II medical device recall Z-0817-2024
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-0817-2024 |
|---|---|
| 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 | 4,394 units |
| UPC / GTIN / UDI-DI | 00191072183255 |
| Lot numbers | 638221, 644221, 654221, 666221, 670221, 682221, 701221, 708221, 714221, 717221, 747221, 766221, 779221, 795221, 807221, 814221, 834221, 846221, 873221, 883231, 912231, 919231, 920231, 924231, 925231, 937231, 952231, 954231, 963231, 973231, 976231, 988231, 991231 |
| Model numbers | SJCA21F |
| Expiration dates | 2023-05-07, 2023-06-02, 2023-06-03, 2023-06-07, 2023-06-15, 2023-07-05, 2023-07-12, 2023-07-24, 2023-07-31, 2023-08-09, 2023-08-22, 2023-09-10, 2023-10-13, 2023-10-19, 2023-10-26, 2023-10-30, 2023-11-14, 2023-11-26, 2023-11-30, 2023-12-12, 2023-12-22, 2024-01-09, 2024-01-12, 2024-01-27, 2024-02-06 and 8 more |
Product
Custom procedural convenience kits and trays, cardiac, labeled as: a) HEART CATHETERIZATION TRAY, kit number JRHC45G; b) TAVR PACK, kit number LLTV10; c) CATH PED LF SJH, kit number SJCA21F; d) CATH HEART ADL LF SJH, kit number SJCH22F; e) INT RAD PORTS-LF - 206060, kit number UDIR58AL
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-0817-2024. 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.