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Terminated

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.

FDA Recall Z-1141-2021 · Posted None

Recalling FirmEcolab Inc
Recall StatusTerminated
Product CodePUI
Date Initiated2021-01-11
Date Terminated2023-01-09
Product Quantity132 cases (3168 drapes)

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.

Firm Action

The firm sent a recall communication letter "Urgent: MEDICAL DEVICE RECALL IMMEDIATE ATTENTION REQUIRED" to customers on 01/11/2021.

Root Cause

Process control

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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