Custom procedural convenience kits and trays — Class II medical device recall Z-0826-2024
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-0826-2024 |
|---|---|
| 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 | 244 units |
| UPC / GTIN / UDI-DI | 00191072117038, 00191072142849, 00191072172006, 00191072189356 |
| Lot numbers | 637221, 680221, 727221, 898231, 911231, 976231, 996231 |
| Expiration dates | 2023-07-26, 2023-09-30, 2023-11-16, 2023-12-29, 2024-01-04, 2024-01-24, 2024-04-12 |
Product
Custom procedural convenience kits and trays, general hospital use, labeled as: a) Baby PICC Kit, kit number UIBP90J; b) Baby PICC Kit, kit number UIBP90K; c) PORT PACK (PS 058330), kit number UIPO82AB; d) Pediatric PICC Kit, kit number UIPP76K;
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-0826-2024. 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.