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Recall Observatory FDA recall evidence

Device product

Epix latis GRASPER, 5mm x 45 cm, REF: C4140, Qty: 10, Sterile R, CE, Rx ONLY, UDI: (01)00607915110154

Z-2159-2020

March 17, 2020

Class II

Product summary

Firm
Applied Medical Resources Corp
Event
Event 85436
Status
Terminated
Classification
Class II
Quantity
4320 units
Official record key
device-enforcement:Z-2159-2020

Official wording

Reason: 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.

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

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.