FDAClass IIJuly 21, 2021

EASYGRIP FLO-41 US. For delivering hemostatic agents to recall

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

Why was EASYGRIP FLO-41 US. For delivering hemostatic agents to recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
EASYGRIP FLO-41 US. For delivering hemostatic agents to bleeding sites through a trocar.
Recalling firm
Baxter Healthcare Corporation
Quantity
4,752 units
Distribution
United States, Australia, Hong Kong, New Zealand, Belgium, Cyprus, Ireland, Italy, Netherlands, Norway, Portugal, Spain, Sweden, and United Kingdom.
Recall date
July 21, 2021
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls