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U.S. Department of Health and Human Services

Class 2 Device Recall IceRod" Cryoablation Needles

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  Class 2 Device Recall IceRod" Cryoablation Needles see related information
Date Initiated by Firm November 18, 2020
Create Date December 22, 2020
Recall Status1 Open3, Classified
Recall Number Z-0665-2021
Recall Event ID 86777
510(K)Number K060390  
Product Classification Unit, cryosurgical, accessories - Product Code GEH
Product IceRod" 1.5 i-Thaw" Cryoablation Needle
Code Information UPN: FPRPR4009  UDIs: 7290104830204, 7290104830204, 7290104830204, 7290104830204, 7290104830204, 7290104830204, 7290104830204, 7290104830204, 7290104830204, 7290104830204, 7290104830204, 7290104830204, 7290104830204, 7290104830204, 7290104830204, 7290104830204, 7290104830204  Batch Numbers: U1362, U1217, U0957, U0283, U0282, U0087, T0819, T0392, A6883, A6657, A2043, A1954, A1669, A1532, A1501, A1476, A1329
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 262 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 = GEH and Original Applicant = GALIL MEDICAL LTD.
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