Ultra/Phonic Focus BP Conforming Gel Pads, UDI 00300361301021 (Primary); 10300361301028 (Package) - Product Usage: A…

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• • Ultra/Phonic Focus BP Conforming Gel Pads
  • UDI 00300361301021 (Primary)
  • 10300361301028 (Package) -
• Product UsageA gel pad for use on woman s areola during an ultrasound examination. Its primary purpose is for patient comfort over the loose gel and helps with nipple location during the scan, making the areola location easier to identify

Lot codes and dates

• Lots

  107 of 107 codes

  • 021805-02
  • 030805-02
  • 050405-02
  • 051106-02
  • 052406-02
  • 101006-02
  • 101806-02
  • 103406-02
  • 052708-02
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  • 101309-02
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  • 030211-02
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  • 011312-02
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  • 030412-02
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  • 061712-02
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  • 120612-02
  • 011013-02
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  • 120613-02
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  • 021314-02
  • 022614-02
  • 030614-02
  • 060914-02
  • 061314-02
  • 062014-02
  • 070714-02
  • 100314-02
  • 101614-02
  • 110914-02
  • 120314-02
  • 020115-02
  • 030115-02
  • 060615-02
  • 061315-02

  Show all 107 codes

Amount recalled

tbd

Where it was sold

• Nationwide
• NV

Why it was recalled

The firm registered the product as a Class I device, but has since been informed by FDA that the device is not Class I and requires a 510(k) submission.

This product could cause temporary or reversible health problems — stop using it.