Product Wiki · Recalls · U.S. FDA — Device Enforcement

Epix latis GRASPER, 5mm x 45 cm, REF: C4140, Qty: 10, Sterile R, CE… — recall Z-2159-2020

U.S. FDA — Device Enforcement · United States · 2020-03-17 · Class II

As described by U.S. FDA — Device Enforcement: Epix latis GRASPER, 5mm x 45 cm, REF: C4140, Qty: 10, Sterile R, CE, Rx ONLY, UDI: (01)00607915110154

Compiled from an official source — the facts on this page are reproduced from the issuing authority’s own published notice, which is linked above. No AI-generated text appears on this page. How we use AI →
Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2159-2020
Date of alert
2020-03-17
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Applied Medical Resources Corp
Product category
device
Product type
Devices
Recall status
Terminated — the recall action is complete and the FDA has closed it
Initiated by
Voluntary: Firm initiated
Distribution
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, In
Barcode (EAN/GTIN)
00607915110154
Reported risk: 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.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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