CLASS II Device recall · Reported 21 Jul 2021 · FDA Enforcement Report

Easygrip Flo-41 Us recalled by Baxter Healthcare

Baxter Healthcare is recalling Easygrip Flo-41 Us. The recall was initiated on 15 Jun 2021 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesProduct Code: ADS201897. Lot Numbers: 0000266641, 0000325839, 0000362640, 0000380266.
Quantity recalled4,752 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number
Z-2051-2021
FDA event ID
88074
Recalling firm
Baxter Healthcare, Deerfield, IL
Classification
Class II
Status
Terminated
Recall initiated
15 Jun 2021
FDA classified
9 Jul 2021
Reported
21 Jul 2021
Type
Voluntary: Firm initiated
Customers notified by
Letter
Reason category
Other Reasons

Timeline

15 Jun 2021Recall initiated by company
9 Jul 2021Classified by FDA+24 days
21 Jul 2021Published in enforcement report+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

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

Where it was distributed

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

Questions about this recall

Is Easygrip Flo-41 Us recalled?

Yes. Baxter Healthcare recalled Easygrip Flo-41 Us on 15 Jun 2021. The recall is Class II and its status is Terminated. Recall number Z-2051-2021.

Why was it recalled?

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

Which lots are affected?

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

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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