Health product recall

IcePearl & IceForce Cryoablation Needle (2020-06-04)

Starting date:
June 4, 2020
Posting date:
June 19, 2020
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-73377



Last updated: 2020-06-19

Affected Products

  1. IcePearl Cryoablation Needle
  2. IceForce Cryoablation Needle

Reason

Injury to a patient during a procedure while using the IceForce Cryoablation Needle.

Affected products

A. IcePearl Cryoablation Needle

Lot or serial number
  • More than 10 numbers, contact manufacturer.
Model or catalog number
  • FPRPR3601
  • FPRPR3603
  • FPRPR3617
Companies
Manufacturer

Galil Medical Ltd.

TAVOR BUILDING 1, INDUSTRIAL PARK, PO BOX 224

YOKNEAM,

2069203

ISRAEL


B. IceForce Cryoablation Needle

Lot or serial number
  • More than 10 numbers, contact manufacturer.
Model or catalog number
  • FPRPR3602
  • FPRPR3604
  • FPRPR3618
Companies
Manufacturer

Galil Medical Ltd.

TAVOR BUILDING 1, INDUSTRIAL PARK, PO BOX 224

YOKNEAM,

2069203

ISRAEL