Z-2159-2020 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- June 3, 2020
- Initiation Date
- March 17, 2020
- Termination Date
- February 17, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4320 units
Product Description
Epix latis GRASPER, 5mm x 45 cm, REF: C4140, Qty: 10, Sterile R, CE, Rx ONLY, UDI: (01)00607915110154
Reason for Recall
There may be a slightly protruding rivet on the distal end of the laparoscopic grasper which has the potential for tissue to catch on it during use and lead to tissue damage.
Distribution Pattern
US: AL, AR, AZ, CA, CO, CT, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY OUS: Argentina, Australia, Austria, Belgium, Canada, Chile, Costa Rica, Denmark, France, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Latvia, Liechtenstein, Luxembourg, Netherlands, New Zealand, Peru, Portugal, Serbia, Singapore, South Africa, Spain, Thailand, United Kingdom
Code Information
Batch: 1366454/ Expiration Date: August 25, 2022; Batch: 1371261/Expiration Date: October 7, 2022; Batch: 1371262/Expiration Date: October 14, 2022; Batch: 1373051/Expiration Date: October 29, 2022; Batch: 1373256/Expiration Date: December 1, 2022; Batch: 1376369/Expiration Date: December 10, 2022