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Recall Observatory FDA recall evidence

Device product

BAUSCH+LOMB, I-PACK Injection Kit, REF 18060, for the administration of intravitreal injection (eye)

Z-2251-2024

June 12, 2024

Class I

Product summary

Firm
Synergetics Inc
Event
Event 94793
Status
Ongoing
Classification
Class I
Quantity
14 units
Official record key
device-enforcement:Z-2251-2024

Official wording

Reason: Sterilization certificates could not be validated by the supplier

Code information: UDI/DI 20841305107544, Lot Number P62764979R

Distribution pattern: US Nationwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Sterilization certificates could not be validated by the supplier