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Recall Observatory FDA recall evidence

Device product

GALAXY G3 Mini Microcoil Delivery System Product No: GLM915030 (3 cm).

Z-2280-2019

May 16, 2019

Class II

Product summary

Firm
Codman & Shurtleff Inc
Event
Event 83502
Status
Terminated
Classification
Class II
Quantity
28 units
Official record key
device-enforcement:Z-2280-2019

Official wording

Reason: Incorrect coil length on the label

Code information: Lot/Serial No: L14364 UDI:10886704080138

Distribution pattern: Japan

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Incorrect coil length on the label