medical Class II Updated 2021-03-03

Ecolab Inc recalls Slush + Warmer Disc Drape; Model ORS-320 Slush + Warmer Disc

Recalled 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.


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Model ORS-320, lot D192619A, 132 cases (3168 drapes)
View official government recall

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