| Class 2 Device Recall IceRod" Cryoablation Needles | |
Date Initiated by Firm | November 18, 2020 |
Create Date | December 22, 2020 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-0693-2021 |
Recall Event ID |
86777 |
510(K)Number | K060390 |
Product Classification |
Unit, cryosurgical, accessories - Product Code GEH
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Product | IceRod" He-Thaw Prostate Cryoablation Kit |
Code Information |
UPN: FPRPR4570 UDIs: 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830105, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099 Batch Numbers:G5063, G5871, G5900, G5902, G5975, P1901, P2150, P2204, P2206, P2207, P2240, P2241, P2242, P2243, P2245, P2247, P2249, P2251, P2253, P2254, P2256, P2258, P2259, P2261, P2262, P2263, P2268, P2272, P2274, P2404, P2405, P2406, P2411 |
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.
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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 | 115 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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