# FDA recall Z-1141-2021

> **Ecolab Inc** · Class II · device recall initiated 2021-01-11.

## Product

Slush + Warmer Disc Drape; Model ORS-320 Slush + Warmer Disc Drapes - Product Usage: single-use equipment cover intended for use during various surgeries where warm irrigation, slush and/or cold solution is required.

## Reason for recall

Slits were identified in a low quantity of ORS-320 Slush + Warmer Disc Drapes from a single lot. A source for potential manufacturing error was identified and investigation is underway to prevent further recurrence. The slits may lead to a breach in the sterile barrier between fluid in the basin and the slush/warming equipment. This could pose a risk of infection to patients receiving warmed irrigation fluid or surgical slush if used during a procedure.

## Distribution

Worldwide distribution - US Nationwide Distribution in the states of AL, AZ, CA, CO, FL, HI, ID, IL, IN, KS, LA, MA, MD, MI, MO, MT, NJ, NY, OH, OK, OR, PA, TN, TX, UT, WA. In the country of Japan.

## Key facts

- **Recall number:** Z-1141-2021
- **Recalling firm:** Ecolab Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-01-11
- **Report date:** 2021-03-03
- **Termination date:** 2023-01-09

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Saint Paul, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1141-2021

## Citation

> AI Analytics. FDA recall Z-1141-2021. Retrieved 2026-07-20 from https://api.ai-analytics.org/recall/Z-1141-2021. Source: US FDA. Licensed CC0.

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