Z-0582-2022 Class II Terminated
FDA device recall Z-0582-2022 was initiated by Microbiologics Inc on October 1, 2020 and is designated Class II. Reason for recall: Potential contamination with S. epidermidis E. coli and S. warneri. The recall status is terminated (terminated July 7, 2022). Affected quantity: 271 units total.
Recall Details
- Product Type
- Devices
- Report Date
- February 16, 2022
- Initiation Date
- October 1, 2020
- Termination Date
- July 7, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 271 units total
Product Description
Reason for Recall
Distribution Pattern
Worldwide distribution - US Nationwide distribution in the states of AR, AZ, CA, CO, DE, FL, GA, IA, IL, IN, KS, LA, MA, MD, ME, MI, MN, MS, MT, NC, ND, NE, NM, NY, OH, OK, OR, PR, SC, TN, TX, VA, VT, WA, WV and the countries of AUSTRALIA, AUSTRIA, BAHRAIN, BELARUS, BELGIUM, BRAZIL, CANADA, CHILE, CHINA, COLOMBIA, FRANCE, GEORGIA, GERMANY, GUATAMALA, HONG KONG, INDIA, INDONESIA, IRELAND, ITALY, JAPAN, JORDAN, LATVIA, MEXICO, NETHERLANDS, PERU, PHILIPPINES, POLAND, ROMANIA, SAUDI ARABIA, SOUTH AFRICA, SWITZERLAND, UNITED ARAB EMIRATES, VIETNAM.