Z-0593-2021 Class I Terminated
FDA device recall Z-0593-2021 was initiated by Cook Inc. on November 24, 2020 and is designated Class I. Reason for recall: There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could result in life-threatening adverse events. The potential adve… The recall status is terminated (terminated September 7, 2022). Affected quantity: 458.
Recall Details
- Product Type
- Devices
- Report Date
- December 30, 2020
- Initiation Date
- November 24, 2020
- Termination Date
- September 7, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 458
Product Description
Reason for Recall
Distribution Pattern
US Nationwide Distribution including states of: AK, CT, IA, LA, MO, NH, OK, TN, WI, AL, DC, ID, MA, MS, NJ, OR, TX, WV, AR, DE, IL, MD, MT, NM, PA, UT, WY, AZ, FL, IN, ME, NC, NV, RI, VA, CA, GA, KS, MI, ND, NY, SC, VT, CO, HI, KY, MN, NE, OH, SD, WA and Global Distribution to: AU, SG, Austria, Belgium, Canary Islands, CN, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, Ireland, Italy, KR, Latvia, Lithuania, MY, Morocco, Netherlands, Norway, Poland, Portugal, Reunion, Russian Federation, Saudi Arabia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, TW, TH, and United Arabs Emirates.