# FDA recall Z-0818-2024

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

## Product

Procedural convenience kits and trays, cardiac, labeled as:    a)	EP LAB BI V IMPLANT PACK, kit number AGBI64J;   b)	LAB DEVICE IMPLANT, kit number AGDI40J;   c)	LAB DEVICE IMPLANT, kit number AGDI40K;   d)	MINOR VASCULAR, kit number AGMV26O;   e)	OPEN HEART ACCESSORY, kit number AGOH98Q;   f)	OPEN HEART ACCESSORY, kit number AGOH98R;   g)	OPEN HEART ACCESSORY, kit number AGOH98S;   h)	PERIPHERAL VASCULAR, kit number AGPV28O;   i)	PERIPHERAL VASCULAR, kit number AGPV28P;   j)	MINOR VASCULAR, kit number AHMV26J;   k)	MINOR VASCULAR, kit number AHMV26K;   l)	HEART PACK - 205947, kit number ANCV78AX;   m)	HEART PACK - 205947 , kit number ANCV78AX1;   n)	HEART PACK - 205947 Post Open-Heart, kit number ANHK74N;   o)	OPEN HEART EAST PACK, kit number BHOH43;   p)	74OFF PUMP CABG PACK, kit number BHOP48;   q)	PACEMAKER PACK, kit number BHPM60;   r)	FORBES EP LAB DEVICE IMPLANT PK, kit number FBDI42K;   s)	T AND A PACK AGH ASC, kit number FBDI42L;   t)	T AND A PACK AGH ASC, kit number FBDI42M; 

## 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-0818-2024
- **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-0818-2024

## Citation

> AI Analytics. FDA recall Z-0818-2024. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0818-2024. Source: US FDA. Licensed CC0.

---

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