Baxter Flow Coupler Monitor Recall Due to Battery Recharge Failure

Plain-English summary

Baxter Healthcare Corporation is recalling 109 units of the FLOW COUPLER Monitor. These are implantable devices intended for vascular use and are available in five sizes: 2.0 mm, 2.5 mm, 3.0 mm, 3.5 mm, and 4.0 mm.

The recall is being conducted because there is a potential for the device's battery to lose its ability to be recharged. The affected devices were distributed nationwide to 40 states, including Arizona, Florida, Ohio, New York, Georgia, Virginia, Massachusetts, Wisconsin, Missouri, Montana, West Virginia, Illinois, North Carolina, New Jersey, Arkansas, California, Colorado, Connecticut, Iowa, Idaho, Indiana, Kansas, Louisiana, Maryland, Michigan, Minnesota, Mississippi, Nebraska, New Hampshire, New Mexico, Nevada, Oklahoma, Oregon, Pennsylvania, Rhode Island, Wyoming, Washington, Vermont, Texas, Tennessee, South Carolina, and South Dakota.

Healthcare providers and patients should check their device serial numbers against the list provided in the official recall notice to determine if their unit is affected. If a device is affected, users should contact Baxter Healthcare Corporation for instructions on replacement or repair.

The recalled product

Product

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.

Manufacturer

Baxter Healthcare Corporation

Category

Medical Device — Implantable Vascular Device

Hazard

• battery-failure
• device-malfunction

Affected units

109

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

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