Z-1908-2024 Class II Ongoing
FDA device recall Z-1908-2024 was initiated by Stryker Neurovascular on April 23, 2024 and is designated Class II. Reason for recall: Neurovascular devices did not meet the minimum sample size required for endotoxin testing during manufacturing processes and are out of compliance with the AAMI ST72 standard, so these devices may exc… The recall status is ongoing. Affected quantity: 81.
Recall Details
- Product Type
- Devices
- Report Date
- June 5, 2024
- Initiation Date
- April 23, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 81
Product Description
Reason for Recall
Distribution Pattern
Worldwide - US Nationwide distribution including in the states of MN, PA, IL, AK, NY, CA, MI, WI, TX, AZ, FL, KY, MA, IN, NE, MT, CT, NJ, TN, VA, AL, CO, DE, OH, UT, NC, ME, GA, SC, GU, WA, MO, OR, DC, OK, LA, MD, ID, NH, SD, NV, RI, ND, HI, MS, AR, IA, NM, VT, KS and the countries of Australia, Austria, Belgium, Brazil, Canada, Canary Islands, Chile, China, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, SAR China, Hungary, India, Ireland, Israel, Italy, Japan, Korea (South), Lithuania, Luxembourg, Netherlands, Northern Ireland, Norway, Poland, Portugal, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, Spain, Sweden, Switzerland, Taiwan, Republic of China, Thailand, Turkey, United Arab Emirates, United Kingdom.