medical MODERATE Updated 2017-03-15

Covidien LLC recalls Premier Guard Drape, Sterile. For Use with Verisphere (01-0

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Recalled Product

Premier Guard Drape, Sterile. For Use with Verisphere (01-0035) and ArQ.Sphere (01-0044) Item Number: 01-0037 Used in conjunction RF Surgical Gauze detection systems to protect scanning device from contamination during various surgical procedures

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Hazard / Issue

Sterility compromised due to breach in sterile barrier

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot Numbers: 1410577-4 to 1605778

✅ 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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