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Recall Observatory FDA recall evidence

Device product

ICSI MICROPIPETTE CooperSurgical part number: MICC001-30-B1.0

Z-1367-2019

March 27, 2019

Class II

Product summary

Firm
CooperSurgical, Inc.
Event
Event 82663
Status
Terminated
Classification
Class II
Quantity
480 units
Official record key
device-enforcement:Z-1367-2019

Official wording

Reason: ICSI CUSTOM MICROPIPETTES the thirty-degree bend is absent

Code information: Lot 1557

Distribution pattern: Foreign: Denmark, Italy, Sweden

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    ICSI CUSTOM MICROPIPETTES the thirty-degree bend is absent