Z-0830-2021 Class II Terminated
FDA device recall Z-0830-2021 was initiated by Steris Corporation on November 19, 2020 and is designated Class II. 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… The recall status is terminated (terminated October 25, 2023). Affected quantity: 23,445 units, Domestic 5,727 units, Foreign 17,718 units.
Recall Details
- Product Type
- Devices
- Report Date
- January 20, 2021
- Initiation Date
- November 19, 2020
- Termination Date
- October 25, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 23,445 units, Domestic 5,727 units, Foreign 17,718 units
Product Description
Reason for Recall
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.