Baxter recalls 5-size Flow Coupler Monitor devices with potential battery recharge issues. Affected units have specific serial numbers and sizes. No remedy stated in recall.
Potential for the battery to lose its ability to be recharged.
Baxter is recalling Flow Coupler Monitor devices that come in 5 sizes. These implantable medical devices may lose their ability to be recharged, which could affect their function. This recall does not include a remedy.
The battery in these devices may lose its ability to be recharged over time. This could lead to the device not functioning properly during medical procedures. However, the recall does not specify how this affects patient safety directly.
Patients using Baxter Flow Coupler Monitor devices for vascular procedures may be affected. Those with specific serial numbers listed in the recall are most at risk.
Check if your device has a serial number from the list provided in the recall (e.g., 135306000279 to 139609000610). The device comes in 5 sizes: 2.0 mm, 2.5 mm, 3.0 mm, 3.5 mm, or 4.0 mm.
Look for the serial number on your device to see if it matches the list of affected numbers provided in the recall.
The recall states that the battery may lose its ability to be recharged, which could affect the device's function during medical procedures.
The recall does not provide a remedy, so no specific action is required beyond checking if your device is affected.
Check if your device has a serial number from the list provided in the recall (e.g., 135306000279 to 139609000610).
We’ve drafted a message you can send Baxter to request your refund or repair — edit it as you like.
Subject: Recall Z-0939-2021 — Baxter Baxter Hello, I own a Baxter that is covered by recall Z-0939-2021 from Baxter. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
