Baxter Healthcare recalls Simple Clamp devices due to adhesive not curing properly, risking loss of holding strength. Affected units include specific model numbers and lot numbers from 2022.
the adhesive, applied to screws and bolts as an additional holding force, may not cure correctly, and as a result, could result in a loss of holding and reduced mechanical integrity.
Baxter Healthcare is recalling Simple Clamp devices that use adhesive to hold screws and bolts. If the adhesive doesn't cure correctly, the device could become less secure during surgery, potentially causing injury.
The adhesive applied to screws and bolts may not cure properly, leading to reduced holding strength. This could cause the device to become loose during surgery, potentially causing injury to the patient.
Surgical patients and healthcare providers using Baxter's Simple Clamp devices for hand, wrist, forearm, or shoulder procedures. Those with the specific model number #800101 and lot number 22-124 are most at risk.
Check for the model number #800101 and lot number 22-124 on the device. The product is used to position, support, and distract patients' limbs during surgical procedures.
Look for model number #800101 and lot number 22-124 on the device.
The adhesive applied to screws and bolts may not cure correctly, which could lead to reduced holding strength and potential injury during surgery.
The recall record does not specify a remedy, so check with Baxter Healthcare for further instructions.
The product may not be safe if the adhesive does not cure correctly, but the recall record does not provide specific safety conditions.
We’ve drafted a message you can send Baxter Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0180-2023 — Baxter Healthcare Baxter Healthcare Hello, I own a Baxter Healthcare that is covered by recall Z-0180-2023 from Baxter Healthcare. 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.
