# FDA recall Z-2978-2018

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

## Product

Laparoscopy CDS

## Reason for recall

One manufacturing lot of a non-sterile pack was assembled with a non-sterile component labeled sterile (kit component #80532NS). The non-sterile component 80532NS was supposed to be placed inside the sterile portion of the pack where it would subsequently be exposed to the ethylene oxide sterilization process. However, the component was not placed in the sterile portion of the pack during assembly and was never exposed to the sterilization process. Component 80532NS was inadvertently released non-sterile. Component 80532NS is packaged by Medline and is an Anti-fog kit that contains 1 bottle of 6g Anti-Fog solution and an adhesive backed sponge.

## Distribution

CA, NM

## Key facts

- **Recall number:** Z-2978-2018
- **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-2978-2018

## Citation

> AI Analytics. FDA recall Z-2978-2018. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-2978-2018. Source: US FDA. Licensed CC0.

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