# FDA recall Z-2979-2018

> **Medline Industries, Inc.** · Class II · device recall initiated 2017-04-12.

## Product

Cardiac Insulation Pad, OPEN HEART CDS

## Reason for recall

Complete delivery System (CDS) # CDS984746C was assembled using a non-sterile cardiac insulation pad, Medline component number 32369. The non-sterile component (32369) was placed within the non-sterile portion of the CDS assembly. This component should have been placed inside the sterile portion of the pack where it would have subsequently been exposed to an ethylene oxide sterilization process. This component was not placed in the sterile portion of the pack and was not sterilized, resulting in the inadvertent release of this item in a non-sterile state. The contents of the sterile kit were properly sterilized and the remaining contents of the non-sterile subassembly had the appropriate sterility status based on their intended use.

## Distribution

CA, NM

## Key facts

- **Recall number:** Z-2979-2018
- **Recalling firm:** Medline Industries, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-04-12
- **Report date:** 2018-09-12
- **Termination date:** 2019-08-05

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Waukegan, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2979-2018

## Citation

> AI Analytics. FDA recall Z-2979-2018. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-2979-2018. Source: US FDA. Licensed CC0.

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