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Recall Observatory FDA recall evidence

Device product

(1) VitreQ 23G BF Blunt Needles-BF23.D51 GTIN#: 8719214221126 (2) VitreQ 23G BF Brush Needles-BF23.D52 GTIN#: 8719214221140

Z-0846-2020

December 17, 2019

Class II

Product summary

Firm
Vitreq Bv
Event
Event 84661
Status
Terminated
Classification
Class II
Quantity
N/A
Official record key
device-enforcement:Z-0846-2020

Official wording

Reason: Microscopic tears of the sterile pouch may compromise sterility

Code information: All lots

Distribution pattern: Nationwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Microscopic tears of the sterile pouch may compromise sterility