Ablation Galil Technology, IceForce 2.1 CX 90 Cyroablation Needles, Prescription Only Galil Medicals 2.1 CX Cryoablation Needles are intended for cryoablative destruction of tissue during surgical procedures.

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    UPN: FPRPR3618 , GTIN: 07290104831089, Batch: X2073, X6812, A0815, A0994, A1044, A1046, A1188, A1189, A1544, A1545, A1774, A1775, A2029, A2030, A6677, A6678, A7032, A7033, A7082, T0134, T0135, T0142, T0143, T0275, T0278, U0160, U0161
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Boston Scientific Corporation
Reason for Recall:
The needle surface deteriorated due to unexpected electrolysis during procedure.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

Ablation Galil Technology, IceForce 2.1 CX 90 Cyroablation Needles, Prescription Only Galil Medicals 2.1 CX Cryoablation Needles are intended for cryoablative destruction of tissue during surgical procedures.

Product Codes/Lot Numbers:

UPN: FPRPR3618 , GTIN: 07290104831089, Batch: X2073, X6812, A0815, A0994, A1044, A1046, A1188, A1189, A1544, A1545, A1774, A1775, A2029, A2030, A6677, A6678, A7032, A7033, A7082, T0134, T0135, T0142, T0143, T0275, T0278, U0160, U0161

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2683-2020

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