Z-1453-2020 Class II Terminated
FDA device recall Z-1453-2020 was initiated by Cardinal Health 200, LLC on January 15, 2020 and is designated Class II. Reason for recall: Non-sterile product was shipped to customers. Product package is labeled as both "STERILE" and "NON-STERILR" ; the product did not undergo sterilization process and is non-sterile. The usage of a nee… The recall status is terminated (terminated December 4, 2020). Affected quantity: 8400 each.
Recall Details
- Product Type
- Devices
- Report Date
- March 18, 2020
- Initiation Date
- January 15, 2020
- Termination Date
- December 4, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8400 each
Product Description
Reason for Recall
Distribution Pattern
Worldwide distributions - US Nationwide distributions in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, and countries of Canada, Australia, South Africa, Belgium, Germany, Ireland, Portugal Spain, and UK.