Five IceSphere" Prostate Cryoablation Kit
Class I - DangerousWhat Should You Do?
- Check if you have this product: UPN: FPRPR3570 UDIs: 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969 Batch Numbers: U1402, U1223, U1224, U1225, U1177, U1178, U1118, U1115, U1070, U1069, U0824, U0825, U0823, U0826, U0470, U0411, U0402, U0407, U0384, U0389, U0216, U0183, U0122, U0154, U0155, T0673, T0672, T0635, T0484, T0483, T0461, T0462, T0373, T0374, T0363, T0362, T0127, T0104, T0103, A7009, A6953, A6952, A6890, A6789, A6737, A2101, A2088, A1629, A1626, A1607, A1577, A1382, A1184
- 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:
Five IceSphere" Prostate Cryoablation Kit
Product Codes/Lot Numbers:
UPN: FPRPR3570 UDIs: 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969 Batch Numbers: U1402, U1223, U1224, U1225, U1177, U1178, U1118, U1115, U1070, U1069, U0824, U0825, U0823, U0826, U0470, U0411, U0402, U0407, U0384, U0389, U0216, U0183, U0122, U0154, U0155, T0673, T0672, T0635, T0484, T0483, T0461, T0462, T0373, T0374, T0363, T0362, T0127, T0104, T0103, A7009, A6953, A6952, A6890, A6789, A6737, A2101, A2088, A1629, A1626, A1607, A1577, A1382, A1184
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0689-2021
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