medical MODERATE Updated 2018-03-28

Covidien LLC recalls Situate Gauze RF and X-Ray detectable. Product Number: G080

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Recalled Product

Situate Gauze RF and X-Ray detectable. Product Number: G0804-16P02CN-1 Situate premium cotton are single use cotton disposable that must be used with the Situate delivery system. The disposable have an attached RF Tag, which is an electrically passive inductor like device that is sewn into the green pouch that you will see on all Situate premium cotton. When activated by magnetic impulses from the scanning devices, the tag resonates a signal that allows for the detection of these cotton disposable.

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Hazard / Issue

This voluntary recall is being conducted due to the potential for failure to detect the affected Situate" gauze - RF and Xray detectable products by the Situate" detection console due to a manufacturing error.

Issued by

FDA

Distribution: U.S.
Lot/Code Info: Lot Number: 170704A UDI: 20884521700861

✅ 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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