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

Class I - Dangerous

🏥 Medical Devices Recalled: August 13, 2020 Pharmaceutical Innovations Other Medical Devices Nationwide

What Should You Do?

Check if you have this product:
Lots 021805-02 030805-02 050405-02 051106-02 052406-02 101006-02 101806-02 103406-02 052708-02 053308-02 060308-02 111208-02 111908-02 112108-02 050309-02 050809-02 101009-02 101309-02 061310-02 061710-02 061910-02 021411-02 021911-02 030211-02 030711-02 070711-02 113211-02 113311-02 011312-02 022112-02 030412-02 030812-02 061712-02 061912-02 070512-02 120612-02 011013-02 011313-02 021413-02 030313-02 051313-02 052713-02 060113-02 120613-02 011414-02 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 070515-02 070815-02 100315-02 100615-02 110315-02 110715-02 120316-02 010416-02 011316-02 020216-02 021016-02 030516-02 052016-02 060316-02 091416-02 092316-02 100616-02 101516-02 102116-02 020517-02 021617-02 030817-02 031517-02 032417-02 040717-02 041017-02 050617-02 060317-02 071217-02 071917-02 080417-02 081717-02 091017-02 091617-02 092317-02 100517-02 021018-02 031318-02 040418-02 040718-02 041118-02 041318-02 041818-02 051218-02 060718-02 020619-02 020919-02
Do not eat it: Even if it looks and smells fine, do not consume this product.
Throw it away or return it: You can return the product to the store for a full refund.
Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:: Pharmaceutical Innovations, Inc.
Reason for Recall:: 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.
Classification:: Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
Status:: terminated

Product Information

Full Description:

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

Product Codes/Lot Numbers:

Lots 021805-02 030805-02 050405-02 051106-02 052406-02 101006-02 101806-02 103406-02 052708-02 053308-02 060308-02 111208-02 111908-02 112108-02 050309-02 050809-02 101009-02 101309-02 061310-02 061710-02 061910-02 021411-02 021911-02 030211-02 030711-02 070711-02 113211-02 113311-02 011312-02 022112-02 030412-02 030812-02 061712-02 061912-02 070512-02 120612-02 011013-02 011313-02 021413-02 030313-02 051313-02 052713-02 060113-02 120613-02 011414-02 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 070515-02 070815-02 100315-02 100615-02 110315-02 110715-02 120316-02 010416-02 011316-02 020216-02 021016-02 030516-02 052016-02 060316-02 091416-02 092316-02 100616-02 101516-02 102116-02 020517-02 021617-02 030817-02 031517-02 032417-02 040717-02 041017-02 050617-02 060317-02 071217-02 071917-02 080417-02 081717-02 091017-02 091617-02 092317-02 100517-02 021018-02 031318-02 040418-02 040718-02 041118-02 041318-02 041818-02 051218-02 060718-02 020619-02 020919-02