Z-2830-2020 Class II Terminated
FDA device recall Z-2830-2020 was initiated by Pharmaceutical Innovations, Inc. on August 13, 2020 and is designated Class II. 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. The recall status is terminated (terminated September 16, 2021). Affected quantity: tbd.
Recall Details
- Product Type
- Devices
- Report Date
- August 26, 2020
- Initiation Date
- August 13, 2020
- Termination Date
- September 16, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- tbd
Product 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.
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.
Distribution Pattern
US Nationwide distribution including in the state of Nevada.
Code Information
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