Recall Z-1141-2021— Ecolab Inc
Class II · Terminated
Class II FDA medical device recall by Ecolab Inc, initiated 2021-01-11, terminated 2023-01-09. FDA's recall record names no specific 510(k) clearance for this event. 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: 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..
- Recalling firm
- Ecolab Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-01-11
- Terminated
- 2023-01-09
- Firm location
- Saint Paul, MN, United States
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.