Medisafe Distal Duck Kit and Duck Bag, Cleaner, ultrasonic, medical instrument - Product Usage: intended to keep instruments moist during transportation between point of use and cleaning as an initial step of reprocessing.
FDA Recall Z-0830-2021 · Posted None
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Recalling FirmSteris Corporation
Recall StatusTerminated
Product CodeFLG
Date Initiated2020-11-19
Date Terminated2023-10-25
Product Quantity23,445 units, Domestic 5,727 units, Foreign 17,718 units
Reason for Recall
STERIS has identified that certain lots of diluted 4-Zyme may contain bacteria, specifically Pseudomonas fluorescens. The presence of this bacteria can cause the color of the detergent to darken over time. There is an improbable risk to users of the product from exposure to this bacteria, and no risk to patients.
Firm Action
On 11/23/2020, STERIS issued Urgent Device Correction notices to customers via courier service. Instructing customers to inspect and destroy any remaining affected products in their inventory. STERIS will provide replacement product at no cost to Customers who have product remaining in stock.
Root Cause
Device Design
Distribution Pattern
Worldwide distribution - US Nationwide distribution including in the states of CA, DE, CO, VA, FL, WA, TX, OH, PA, MA, IA, CT and the countries of United Kingdom, Saudi Arabia, Portugal, Denmark, Ireland, United Arab Emirates, South Korea, Australia, Greece, Ashmore & Cartier Islands, Belgium, Canada, China, Germany, Japan, Norway, Poland, Qatar, Romania, Sweden, Thailand.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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