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Recall Observatory FDA recall evidence

Device product

VitreQ 23G PFC Injection Needle- Ref: MD23.D01 GTIN: 8719214221362

Z-0849-2020

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-0849-2020

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