Z-1141-2021 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- March 3, 2021
- Initiation Date
- January 11, 2021
- Termination Date
- January 9, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 132 cases (3168 drapes)
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.
Distribution Pattern
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.
Code Information
Model ORS-320, lot D192619A, 132 cases (3168 drapes)