Z-1073-2021 Class II Terminated
FDA device recall Z-1073-2021 was initiated by Argon Medical Devices, Inc on December 10, 2020 and is designated Class II. Reason for recall: Due to a manufacturing error their is a potential that the sheath within the biopsy kit can separate during use if the tip is flexed or experiences bending stresses. This could result in need for su… The recall status is terminated (terminated January 31, 2023). Affected quantity: 863 unit.
Recall Details
- Product Type
- Devices
- Report Date
- February 17, 2021
- Initiation Date
- December 10, 2020
- Termination Date
- January 31, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 863 unit
Product Description
Reason for Recall
Distribution Pattern
US: AL AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA,, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, TN, TX,, UT, VA, WA, WI, WV, WY OUS: Switzerland, Saudi Arabia, Hong Kong, Thailand, Portugal, Taiwan, Austria, Brazil, Netherlands, Italy, Germany, Colombia, Singapore, Canada, View Nam, Slovakia, Spain