Home / Recalls / Applied Medical Resources Corp / Z-0509-2020

Z-0509-2020 Class II Terminated

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

Recall Details

Product Type
Devices
Report Date
November 27, 2019
Initiation Date
December 12, 2018
Termination Date
January 22, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
28 units Domestically - 112 units Internationally

Product Description

Epix Electrosurgical Probes with Smoke Evacuation, Angled L-Hook Tip, 5mm x 42 cm REF CW002 QTY: 1 - Product Usage: The Epix Electrosurgical Probe with Smoke Evacuation is intended to deliver energy from an independent monopolar electrosurgical generator to cut and coagulate tissue during laparoscopic surgical procedures where the device is introduced into the body through a cannula. The device may be used for the evacuation of smoke created by electrosurgery at the surgical site.

Reason for Recall

Unintentional shifting of the tip insulation of the firm's electrosurgical probes.

Distribution Pattern

Worldwide distribution - US Nationwide distribution and countries of Belgium; Germany; Switzerland; Spain; Finland; France; Great Britain; Israel; India; Italy; Lebanon; Netherlands; and Portugal.

Code Information

Model Number: CW002 Lot Numbers: 1336418 and 1340803 Model # Lot # UDI Code CW002 1336418 (01)00607915136147(17)210912(30)01(10)1336418 CW002 1340206 (01)00607915136147(17)211029(30)01(10)1340206 TA211 1340118 (01)20607915139050(17)210812(30)01(10)1340118 TA211 1342169 (01)20607915139050(17)210812(30)01(10)1342169

Other recalls by Applied Medical Resources Corp

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  • 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-2159-2020 Class II — Epix latis GRASPER, 5mm x 45 cm, REF: C4140, Qty: 10, Sterile R, CE, Rx ONLY, UD (March 17, 2020)
  • Z-2160-2020 Class II — DR. THAMES - LAP CHOLE, REF: K0880, UDI: (01)30607915139620 (March 17, 2020)
  • 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-2035-2020 Class II — STEALTH SPRING CLIP 6mm latis (1/4 Force). REF/UDI::A1602/(01)00607915110574 - 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)
  • Z-2036-2020 Class II — STEALTH SPRING CLIP 6mm latis (3/4 Force). REF/UDI::A1603/(01)00607915110581 - P (January 31, 2020)