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Recall Observatory FDA recall evidence

Device product

Kit, Port Access Product Code: DYNDC1582A

Z-0255-2020

July 15, 2019

Class II

Product summary

Firm
Centurion Medical Products Corporation
Event
Event 83542
Status
Terminated
Classification
Class II
Quantity
11260 kits
Official record key
device-enforcement:Z-0255-2020

Official wording

Reason: Supplier initiated recall of the GRIPPER Needles

Code information: Lot Number Expiration 2018121350 8/31/2020 2019020750 9/30/2020 2019031550 4/30/2021 2019041550 4/30/2021 2019061750 1/31/2021 2019062450 4/30/2021

Distribution pattern: IL

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Supplier initiated recall of the GRIPPER Needles