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Z-2159-2020 Class II Terminated

Recalled by Applied Medical Resources Corp — Rancho Santa Margarita, CA

FDA device recall Z-2159-2020 was initiated by Applied Medical Resources Corp on March 17, 2020 and is designated Class II. 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. The recall status is terminated (terminated February 17, 2022). Affected quantity: 4320 units.

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

Other recalls by Applied Medical Resources Corp

  • Z-1010-2026 Class II — Kii Low Profile, Bladed Dual Pack , Qty. 1 5x55mm REF: CTB23 (December 11, 2025)
  • Z-1388-2024 Class II — Epix Universal Clip Applier, REF: CA500, STERILEEO (January 30, 2024)
  • Z-1389-2024 Class II — Epix Universal Clip Applier, REF: CA500, STERILEEO included within the following (January 30, 2024)
  • Z-2158-2020 Class II — Epix latis GRASPER, 5 mm x 35 cm, REF C4130, Qty: 10, Sterile R, CE, Rx ONLY, U (March 17, 2020)
  • Z-2161-2020 Class II — Clip Applier Kit, REF: K2887, UDI: (01)30607915139132(17)220822(30)1(10) (March 17, 2020)
  • Z-2160-2020 Class II — DR. THAMES - LAP CHOLE, REF: K0880, UDI: (01)30607915139620 (March 17, 2020)
  • Z-2034-2020 Class II — STEALTH SPRING CLIP 6mm latis (1/2 Force). REF/UDI::A1601/(01)00607915110567 - P (January 31, 2020)
  • Z-2035-2020 Class II — STEALTH SPRING CLIP 6mm latis (1/4 Force). REF/UDI::A1602/(01)00607915110574 - P (January 31, 2020)
  • Z-2036-2020 Class II — STEALTH SPRING CLIP 6mm latis (3/4 Force). REF/UDI::A1603/(01)00607915110581 - P (January 31, 2020)
  • Z-2037-2020 Class II — STEALTH SPRING CLIP 6mm latis (1/4 Force). Non-Sterile, REF/UDI::A1702/(01)10607 (January 31, 2020)

FDA data resources