Ecolab Inc Recall 87173
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.
Ecolab Inc Recall 87173 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1141-2021 |
| Event ID | 87173 |
| Event 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. |
| Product Type | Devices |
| 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. |
| Quantity | 132 cases (3168 drapes) |
| Recall 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. |
| Device Classification | 20210303 |
| Device Code Info | Model ORS-320, lot D192619A, 132 cases (3168 drapes) |
| Center Classification Date | 20210222 |
| Recall Initiation Date | 20210111 |
| Recalling Firm | Ecolab Inc |
| Similar To |