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U.S. Department of Health and Human Services

Class 2 Device Recall IceFORCE" Cryoablation Needles

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  Class 2 Device Recall IceFORCE" Cryoablation Needles see related information
Date Initiated by Firm November 18, 2020
Create Date December 22, 2020
Recall Status1 Open3, Classified
Recall Number Z-0659-2021
Recall Event ID 86777
510(K)Number K162599  
Product Classification Electrosurgical, cutting & coagulation & accessories - Product Code GEI
Product IceFORCE" 2.1 CX L 90¿ Cryoablation Needle
Code Information UPN: FPRPR3618  UDIs: 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089  Batch Numbers: U1214, U1215, U1112, U1113, U0958, U0959, U0861, U0862, U0765, U0766, U0729, U0730, U0645, U0643, U0644, U0642, U0426, U0425, U0408, U0160, U0161, T0278, T0275, T0143, T0142, T0134, T0135, A7082, A7032, A7033, A6677, A6678, A2030, A2029, A1775, A1774, A1658, A1544, A1545, A1526, A1188, A1189
Recalling Firm/
Manufacturer		 Boston Scientific Corporation
1 Scimed Pl
Maple Grove MN 55311-1565
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 740 units
Distribution Nationwide
Total Product Life Cycle TPLC Device Report
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.
510(K) Database 510(K)s with Product Code = GEI and Original Applicant = GALIL MEDICAL LTD.
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