Ultra/Phonic Focus BP Conforming Gel Pads recall
Ultra/Phonic Focus BP Conforming Gel Pads, UDI 00300361301021 (Primary); 10300361301028 (Package) - Product Usage: A gel pad for use on woman s areola…
Why was Ultra/Phonic Focus BP Conforming Gel Pads 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- Ultra/Phonic Focus BP Conforming Gel Pads, UDI 00300361301021 (Primary); 10300361301028 (Package) - Product Usage: A gel pad for use on woman s areola…
- Recalling firm
- Pharmaceutical Innovations, Inc.
- Quantity
- tbd
- Distribution
- US Nationwide distribution including in the state of Nevada.
- Recall date
- August 26, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)