medical MODERATE Updated 2022-11-09

Baxter Healthcare Corporation recalls Simple Clamp, US/EURO Rails, UPPER EXTREMITY DISTRACTION CMP

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Recalled Product

Simple Clamp, US/EURO Rails, UPPER EXTREMITY DISTRACTION CMPT, REF F-40018, #800101. To position, support and/or distract the patients hand, wrist, forearm, arm, and shoulder in surgical procedures.

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Hazard / Issue

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.

Issued by

FDA

Affected States: MI, WI, WA, TX
Lot/Code Info: UDI/DI 00615521012731, Lot Number: 22-124

✅ What Should You Do?

  1. 1Contact your healthcare provider immediately to discuss this recall.
  2. 2Stop using the device if it is safe to do so, and contact your provider.
  3. 3Follow the manufacturer's remedy instructions provided in the recall notice.
  4. 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.

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