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Class 2 Device Recall Three IcePearl" Cryoablation Needles |
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Date Initiated by Firm |
November 18, 2020 |
Create Date |
December 22, 2020 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-0685-2021 |
Recall Event ID |
86777 |
510(K)Number |
K152133
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Product Classification |
Unit, cryosurgical, accessories - Product Code GEH
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Product |
Three IcePearl" 2.1 CX Prostate Cryoablation Kit |
Code Information |
UPN: FPRPR3608 UDIs: 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065 Batch Numbers: U1308, U1304, U1066, U1034, U0859, U0860, U0661, U0660, U0609, U0588, T0815, T0816, T0270, T0238, T0212, T0211, T0181, T0144, T0055, A7122, A7027, A7014, A6926, A6913, A6900, A6857, A6744, A6710, A1937, A1583, A1461 |
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
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Manufacturer Reason for Recall |
Complaint trend regarding needle shaft gas leaks.
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FDA Determined Cause 2 |
Under Investigation by firm |
Action |
Customers will be sent a product advisory via overnight mail. |
Quantity in Commerce |
117 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 and Original Applicant = GALIL MEDICAL LTD
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