Recall Z-2051-2021— Baxter Healthcare Corporation

Name: FDA recall Z-2051-2021
Creator: U.S. Food and Drug Administration
Published: 2021-06-15

Class II · Terminated

Class II FDA medical device recall by Baxter Healthcare Corporation, initiated 2021-06-15, terminated 2024-01-12. It names one FDA 510(k) clearance: K193137. Product: EASYGRIP FLO-41 US. For delivering hemostatic agents to bleeding sites through a trocar.. Reason: There is a discrepancy in the expiry date encoded into the 2D barcode. The correct expiration date is the human-readable date.

Recalling firm: Baxter Healthcare Corporation
Classification: Class II
Status: Terminated
Initiated: 2021-06-15
Terminated: 2024-01-12
Firm location: Deerfield, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K193137 — EASYGRIP FLO-41 Precision MIS Delivery SystemBaxter Healthcare Corportation·cleared 2020-01-08

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.