Trident Endoscopic Ultrasonic Biopsy Needle (FNB)
FDA Recall Z-1877-2018 · Posted None
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Recalling FirmMicro-Tech (Nanjing) Co., Ltd.
Recall StatusTerminated
Product CodeODG
Date Initiated2018-03-12
Date Terminated2018-08-30
Product Quantity40 total
Reason for Recall
The combination of the firmness of the mass, the potential endoscope and elevator position combined with the force required to penetrate the mass may contribute to the breakage of the needle in the human body, which could cause injury.
Firm Action
The firm emailed the distributor on March 12, 2018. (initial consignee). The consignee has been requested to return all products to the Manufacturer (Micro-Tech Nanjing).
Root Cause
Device Design
Distribution Pattern
US distribution to one distributor in MI.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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