| Class 2 Device Recall Three IceFORCE" | |
Date Initiated by Firm | November 18, 2020 |
Create Date | December 22, 2020 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-0684-2021 |
Recall Event ID |
86777 |
510(K)Number | K152133 |
Product Classification |
Unit, cryosurgical, accessories - Product Code GEH
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Product | Three IceFORCE" 2.1 CX Prostate Cryoablation Kit |
Code Information |
UPN: FPRPR3607 UDIs: 7290104831058, 7290104831058, 7290104831058, 7290104831058, 7290104831058, 7290104831058, 7290104831058, 7290104831058, 7290104831058, 7290104831058, 7290104831058, 7290104831058, 7290104831058, 7290104831058, 7290104831058, 7290104831058, 7290104831058, 7290104831058, 7290104831058, 7290104831058, 7290104831058, 7290104831058, 7290104831058, 7290104831058, 7290104831058, 7290104831058 Batch Numbers: U1302, U1303, U1301, U1032, U0616, U0590, U0589, U0583, U0540, U0363, U0318, U0083, T0552, T0163, T0154, A6915, A6849, A6848, A6757, A6754, A1782, A1569, A1567, A1436, A1298, A1194 |
Recalling Firm/ Manufacturer |
Boston Scientific Corporation 1 Scimed Pl Maple Grove MN 55311-1565
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For Additional Information Contact | Nicole Pshon 763-494-1700 |
Manufacturer Reason for Recall | Complaint trend regarding needle shaft gas leaks. |
FDA Determined Cause 2 | Under Investigation by firm |
Action | Customers will be sent a product advisory via overnight mail. |
Quantity in Commerce | 140 units |
Distribution | Nationwide |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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510(K) Database | 510(K)s with Product Code = GEH
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