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Recall Observatory FDA recall evidence

Device product

CIVCO Needle Guide, REF 676-150, QTY 24, STERILE EO

Z-2947-2018

July 30, 2018

Class II

Product summary

Firm
Civco Medical Instruments Co. Inc.
Event
Event 80656
Status
Terminated
Classification
Class II
Quantity
3 units
Official record key
device-enforcement:Z-2947-2018

Official wording

Reason: The assembly of the needle guides were found to be either missing adhesive or did not have adequate adhesive to hold the assembled cannula in place on the needle guide.

Code information: UDI 00841436107334, Lot numbers: A035054, A042207

Distribution pattern: United States, Austria, Belgium, Denmark, France, Germany, Poland, Spain, Switzerland and United Kingdom

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The assembly of the needle guides were found to be either missing adhesive or did not have adequate adhesive to hold the assembled cannula in place on the needle guide.