IceRod" i-Thaw" Prostate Cryoablation Kit
Class I - DangerousWhat Should You Do?
- Check if you have this product: UPN: FPRPR4070 UDIs: 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830105 Batch Numbers: U1363, U0865, U0555, U0542, U0151, U0150, U0054, U0053, U0046, U0037, U0036, T0633, T0515, T0430, T0274, T0273, T0201, T0188, T0167, A7174, A7100, A7044, A7022, A7021, A6788, A6740, A2117, A2019, A1968, A1753, A1605, A1535, A1430, A1429, A1235, U1262, U1114, U1036, U0910, U0909, U0863, U0365, U0280, U0281, U0180, U0088, U0038, T0529, T0457, T0235, T0178, T0058, A6911, A6835, A6695, A6648, A2133, A2040, A2033, A1889, A1634, A1368, A1225, G5063, G5871, G5900, G5902, G5975, P1901
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- 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" i-Thaw" Prostate Cryoablation Kit
Product Codes/Lot Numbers:
UPN: FPRPR4070 UDIs: 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830105 Batch Numbers: U1363, U0865, U0555, U0542, U0151, U0150, U0054, U0053, U0046, U0037, U0036, T0633, T0515, T0430, T0274, T0273, T0201, T0188, T0167, A7174, A7100, A7044, A7022, A7021, A6788, A6740, A2117, A2019, A1968, A1753, A1605, A1535, A1430, A1429, A1235, U1262, U1114, U1036, U0910, U0909, U0863, U0365, U0280, U0281, U0180, U0088, U0038, T0529, T0457, T0235, T0178, T0058, A6911, A6835, A6695, A6648, A2133, A2040, A2033, A1889, A1634, A1368, A1225, G5063, G5871, G5900, G5902, G5975, P1901
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0691-2021
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