FDA Devices Moderate Class II Ongoing

FLOW COUPLER Monitor Flow Coupler devices are sold in 5 sizes (2.0 mm, 2.5 mm, 3.0 mm, 3.5 mm, 4.0 mm). Implantable device for vascular use.

Reported: February 10, 2021 Initiated: December 28, 2020 #Z-0939-2021

Product Description

Reason for Recall

Potential for the battery to lose its ability to be recharged.

Details

Recalling Firm: Baxter Healthcare Corporation
Units Affected: 109 units
Distribution: Distributed nationwide to AZ, FL, OH, NY, GA, VA, MA, WI, MO, MT, WV, IL, NC, NJ, AR, CA, CO, CT, IA, ID, IN, KS, LA, MD, MI, MN, MS, NE, NH, NM, NV, OK, OR, PA, RI, WY, WA, VT, TX, TN, SC, SD
Location: Deerfield, IL

Frequently Asked Questions

What product was recalled? ▼

FLOW COUPLER Monitor Flow Coupler devices are sold in 5 sizes (2.0 mm, 2.5 mm, 3.0 mm, 3.5 mm, 4.0 mm). Implantable device for vascular use.. Recalled by Baxter Healthcare Corporation. Units affected: 109 units.

Why was this product recalled? ▼

Potential for the battery to lose its ability to be recharged.

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on February 10, 2021. Severity: Moderate. Recall number: Z-0939-2021.