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Completed

IceRod" i-Thaw" Prostate Cryoablation Kit

FDA Recall Z-0686-2021 · Posted None

Recalling FirmBoston Scientific Corporation
Recall StatusCompleted
Product CodeGEH
Date Initiated2020-11-18
Product Quantity947 units

Reason for Recall

Complaint trend regarding needle shaft gas leaks.

Firm Action

Customers will be sent a product advisory via overnight mail.

Root Cause

Under Investigation by firm

Distribution Pattern

Nationwide

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K060390SEEDNET, SEEDNET GOLD, CRYOHIT, CRYO THERAGalil Medical , Ltd. · 2006-04-27

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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