Reported Mar 3, 2021 · Terminated

Slush + Warmer Disc Drape; Model ORS-320 Slush + Warmer Disc Drapes - Product Usage: single-use equipment cover…

Ecolab Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Ecolab Inc · 1 Ecolab Pl · Saint Paul, MN · 55102-2739

Is this the product you have?

  • Slush + Warmer Disc Drape; Model ORS-320 Slush +
  • Warmer Disc Drapes - Product Usagesingle-use equipment cover intended for use during various surgeries where warm irrigation, slush and/or cold solution is required
Lot codes and dates
    • Model ORS-320
    • lot D192619A
    • 132 cases (3168 drapes)
Amount recalled
132 cases (3168 drapes)

Where it was sold

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jan 9, 2023 · Data as of Sep 19, 6:20 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.