Z-0118-2023 Class II Ongoing
FDA device recall Z-0118-2023 was initiated by ZOLL Circulation, Inc. on September 22, 2022 and is designated Class II. Reason for recall: Due to increase in Li-Ion Battery failures The recall status is ongoing. Affected quantity: 6,353 batteries.
Recall Details
- Product Type
- Devices
- Report Date
- November 2, 2022
- Initiation Date
- September 22, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6,353 batteries
Product Description
Reason for Recall
Distribution Pattern
U.S.: AK, AL, AR, AZ, CA, CO, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, RN, TX, UT, VA, VT, Virgin Islands, WA, WI, WV and WY. O.U.S.: United Arab Emirates, Austria, Australia, Azerbaijan, Brazil, Belarus, Canada, Switzerland, China, Costa Rica, Germany, Denmark, Egypt, France, United Kingdom, Greece, Hong Kong, Croatia, Hungary, Israel, India, Iraq, Italy, Jordan, Japan, South Korea, Moldova, Mexico, Malaysia, Netherlands, Norway, Panama, Philippines, Poland, Qatar, Romania, Russian, Saudi Arabia, Singapore, Slovenia, Taiwan, and Vietnam.