Z-2142-2021 Class II Terminated
FDA device recall Z-2142-2021 was initiated by Remel Inc on June 18, 2021 and is designated Class II. Reason for recall: Out of Specification The recall status is terminated (terminated August 4, 2023). Affected quantity: 327 units.
Recall Details
- Product Type
- Devices
- Report Date
- August 4, 2021
- Initiation Date
- June 18, 2021
- Termination Date
- August 4, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 327 units
Product Description
ThermoScientific Oxoid Antimicrobial Susceptibility Discs Rx only Made in the United Kingdom
Reason for Recall
Out of Specification
Distribution Pattern
Worldwide distribution - US Nationwide distribution including in the states of AL, AR, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, NC, NE, NH, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV, WY, District of Columbia, Hawaii and Puerto Rico. The countries of BERMUDA.
Code Information
Model: CT0223B Lots#'s: 2341375, 2343397, 2394162, 2403210, 2438023, 2463120, 2408058, 2438086, 2457651, 2832507, 2840771, 2935065, 2958576, 2968037 and 2978564 UDI-DI: 05032384006533