Z-0713-2022 Class II Terminated
FDA device recall Z-0713-2022 was initiated by Microbiologics Inc on Oct 6, 2014 and is designated Class II. Reason for recall: This strain should be resistant to high levels of Gentamicin and be resistant to Gentamicin Synergy. A specific lot was found susceptible to Gentamicin Synergy during in-house testing. The recall status is terminated (terminated Jan 17, 2023). Affected quantity: 153 units.
Recall Details
- Product Type
- Devices
- Report Date
- Mar 9, 2022
- Initiation Date
- Oct 6, 2014
- Termination Date
- Jan 17, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 153 units
Product Description
Reason for Recall
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of Argentina, Belgium, Brazil, Canada, Chile, China, Colombia, Croatia/Hrvatska, Ecuador, Finland, France, Germany, Guam, Guatemala, Hong Kong, India, Ireland, Israel, Italy, Japan, Kenya, Republic of Korea, Latvia, Macedonia, Malaysia, Netherlands, Panama, Peru, Poland, Portugal, Puerto Rico, Romania, Saudi Arabia, Singapore, South Africa, Switzerland, Taiwan, Tanzania, Thailand, Turkey, Uganda, United Arab Emirates, and Vietnam.
Code Information
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0713-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026