# FDA recall Z-1163-2023

> **MEDLINE INDUSTRIES, LP - Northfield** · Class II · device recall initiated 2022-12-27.

## Product

(1) Medline Sterile Hand Pack, Item DYNJ63380A, 3 kits per case, contains BD Chloraprep Hi-Lite Orange, 26 mL Applicator, Vendor PN: 930815NS; and    (2) Medline Sterile Hand Pack, Item DYNJ63380C, 3 kits per case, contains BD Chloraprep Hi-Lite Orange, 26 mL Applicator, Vendor PN: 930815NS.

## Reason for recall

The convenience trays had improper placement of some of the components that were in the nonsterile portion of the tray, thus, not receiving sterilization.

## Distribution

US Nationwide distribution in the states of AR, CO, and GA. There was no foreign/military/government distribution.

## Key facts

- **Recall number:** Z-1163-2023
- **Recalling firm:** MEDLINE INDUSTRIES, LP - Northfield
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-12-27
- **Report date:** 2023-03-01

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1163-2023

## Citation

> AI Analytics. FDA recall Z-1163-2023. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-1163-2023. Source: US FDA. Licensed CC0.

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