# FDA recall Z-0831-2024

> **American Contract Systems, Inc.** · Class II · device recall initiated 2023-11-29.

## Product

Custom procedural convenience kits and trays, Obstetrical & Gynecological use, labeled as:    a) LavH, kit number BBLV21C;   b) LAP HYST   247540, kit number BFHY75U

## 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.

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-0831-2024
- **Recalling firm:** American Contract Systems, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-11-29
- **Report date:** 2024-02-07

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Temple Terrace, FL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0831-2024

## Citation

> AI Analytics. FDA recall Z-0831-2024. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-0831-2024. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*