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U.S. Department of Health and Human Services

Class 2 Device Recall Slush Warmer Disc Drape

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  Class 2 Device Recall Slush Warmer Disc Drape see related information
Date Initiated by Firm January 11, 2021
Create Date February 22, 2021
Recall Status1 Open3, Classified
Recall Number Z-1141-2021
Recall Event ID 87173
Product Classification Drape, surgical, exempt - Product Code PUI
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.
Code Information Model ORS-320, lot D192619A, 132 cases (3168 drapes)
Recalling Firm/
Manufacturer
Ecolab Inc
1 Ecolab Pl
Saint Paul MN 55102-2739
For Additional Information Contact Roman Blahoski
651-250-4385
Manufacturer 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.
FDA Determined
Cause 2
Process control
Action The firm sent a recall communication letter "Urgent: MEDICAL DEVICE RECALL IMMEDIATE ATTENTION REQUIRED" to customers on 01/11/2021.
Quantity in Commerce 132 cases (3168 drapes)
Distribution Worldwide distribution - US Nationwide Distribution in the states of AL, AZ, CA, CO, FL, HI, ID, IL, IN, KS, LA, MA, MD, MI, MO, MT, NJ, NY, OH, OK, OR, PA, TN, TX, UT, WA. In the country of Japan.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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