IceRod" He-Thaw Prostate Cryoablation Kit

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    UPN: FPRPR4570 UDIs: 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830105, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099 Batch Numbers:G5063, G5871, G5900, G5902, G5975, P1901, P2150, P2204, P2206, P2207, P2240, P2241, P2242, P2243, P2245, P2247, P2249, P2251, P2253, P2254, P2256, P2258, P2259, P2261, P2262, P2263, P2268, P2272, P2274, P2404, P2405, P2406, P2411
  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:
Complaint trend regarding needle shaft gas leaks.
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

IceRod" He-Thaw Prostate Cryoablation Kit

Product Codes/Lot Numbers:

UPN: FPRPR4570 UDIs: 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830105, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099 Batch Numbers:G5063, G5871, G5900, G5902, G5975, P1901, P2150, P2204, P2206, P2207, P2240, P2241, P2242, P2243, P2245, P2247, P2249, P2251, P2253, P2254, P2256, P2258, P2259, P2261, P2262, P2263, P2268, P2272, P2274, P2404, P2405, P2406, P2411

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0693-2021

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