# FDA recall Z-2976-2018

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

## Product

Art-Line Surgery Pack-LF, STERILE, 40 packs each per case.

## Reason for recall

Multiple surgical packs were assembled with a non-sterile CHG disk labeled as BIOPATCH" (kit component #52655) attached to the outside of the sterile pack. This may pose potential risk of infection. However, the kits have been in distribution since March 2016. Many of these kits have been used with no reported infections or adverse patient events. In addition, the BIOPATCH is impregnated with CHG, a well-known antiseptic agent with broad-spectrum anti-microbial and antifungal activity.

## Distribution

CA, NM

## Key facts

- **Recall number:** Z-2976-2018
- **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-2976-2018

## Citation

> AI Analytics. FDA recall Z-2976-2018. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-2976-2018. Source: US FDA. Licensed CC0.

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