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Recall Observatory FDA recall evidence

Device product

EASYGRIP FLO-41 US. For delivering hemostatic agents to bleeding sites through a trocar.

Z-2051-2021

June 15, 2021

Class II

Product summary

Firm
Baxter Healthcare Corporation
Event
Event 88074
Status
Terminated
Classification
Class II
Quantity
4,752 units
Official record key
device-enforcement:Z-2051-2021

Official wording

Reason: There is a discrepancy in the expiry date encoded into the 2D barcode. The correct expiration date is the human-readable date

Code information: Product Code: ADS201897. Lot Numbers: 0000266641, 0000325839, 0000362640, 0000380266.

Distribution pattern: United States, Australia, Hong Kong, New Zealand, Belgium, Cyprus, Ireland, Italy, Netherlands, Norway, Portugal, Spain, Sweden, and United Kingdom.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    There is a discrepancy in the expiry date encoded into the 2D barcode. The correct expiration date is the human-readable date