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-320lot D192619A132 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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