Z-2051-2021Class II

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

Name: Z-2051-2021 EASYGRIP FLO-41 US. For delivering hemostatic agents to bleeding sites through a trocar
Creator: Baxter Healthcare Corporation
Published: 2021-06-15
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2021-06-15 / Terminated / root cause: manufacturing process

FDA source

Baxter Healthcare Corporation began a recall of EASYGRIP FLO-41 US. For delivering hemostatic agents to bleeding sites through a trocar on 2021-06-15. FDA classified it as Class II and gives the reason as "There is a discrepancy in the expiry date encoded into the 2D barcode. The correct expiration date is the human-readable date". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2051-2021
Classification: Class II
Status: Terminated
Initiated: 2021-06-15
Posted: 2021-07-26
Terminated: 2024-01-12
Recalling firm: Baxter Healthcare Corporation
Product: EASYGRIP FLO-41 US. For delivering hemostatic agents to bleeding sites through a trocar.
Product code: GCJ Laparoscope, General & Plastic Surgery
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
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: On June 15th 2021, the firm sent a letter to its customers with the following instructions: 1. Healthcare providers may continue to safely use the EASYGRIP FLO-41 delivery system while following the human readable expiry date printed on the primary and secondary package labeling, which are also listed in the table above. 2. If you received this communication directly from Baxter, complete the enclosed Baxter customer reply form and return it to Baxter by e-mailing it to [email protected], even if you do not have any inventory. Returning the customer reply form promptly will confirm your receipt of this notification and prevent you from receiving repeat notices. If you do not return the customer reply form, you will receive a phone call from OnProcess Technology on behalf of Baxter to confirm your receipt of this notification. 3. If you distribute this product to other facilities or departments within your institution, please forward a copy of this communication to them.
Quantity in commerce: 4,752 units
Distribution: United States, Australia, Hong Kong, New Zealand, Belgium, Cyprus, Ireland, Italy, Netherlands, Norway, Portugal, Spain, Sweden, and United Kingdom.
Product codes and lots: Product Code: ADS201897. Lot Numbers: 0000266641, 0000325839, 0000362640, 0000380266.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2051-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2051-2021	Class II	Terminated	Voluntary: Firm initiated	2021-07-21	2021-07-09

Product code GCJ

K193137Class IIEASYGRIP FLO-41 Precision MIS Delivery SystemBaxter Healthcare Corportation / cleared 2020-01-08

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)