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
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.
What You Should Do
Remedy
The firm sent a recall communication letter "Urgent: MEDICAL DEVICE RECALL IMMEDIATE ATTENTION REQUIRED" to customers on 01/11/2021.
Affected by this recall?
Get a free legal consultation about this recall.
Talk to a Lawyer →Affiliate link
Products
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 solut
- Brand
- Ecolab Inc
- UPC
- Model ORS-320, lot D192619A, 132 cases (3168 drapes)
Units Affected
132 cases (3168 drapes)