Breast Plastics Pack — Class II medical device recall Z-0173-2024
Ongoing recall by American Contract Systems, Inc., reported 2023-11-01, distributed nationwide. During an internal investigation, ACS identified that the components, I.V. Cath (part number 4252535-02) and A
| Recall number | Z-0173-2024 |
|---|---|
| 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 | 2023-09-01 |
| Classified | 2023-10-26 |
| Reported by FDA | 2023-11-01 |
| Distributed | Nationwide (US) |
| Quantity | 20 cases |
| UPC / GTIN / UDI-DI | 00191072166241 |
| Lot numbers | 756221, 782221, 862221 |
| Model numbers | BBPL20D |
Product
Breast Plastics Pack, REF BBPL20D
Reason for recall
During an internal investigation, ACS identified that the components, I.V. Cath (part number 4252535-02) and Adhesive Dermabond (part number DHVM12) were inadvertently subjected to the ACS sterilization process and exposed to EO and higher temperatures than approved by the component manufacturer. As a result, the components may (1) have a loss/lack of functionality, (2) loss of drug efficacy, if applicable, and (3) have 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-0173-2024. 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.