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Stradis Medical, LLC dba Stradis Healthcare Recall 88656

Description: IUD Insertion Kit

Stradis Medical, LLC dba Stradis Healthcare Recall 88656 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0128-2022
Event ID88656
Event DescriptionIUD Insertion Kit
Product TypeDevices
DistributionDistributed nationwide to VA, SC, CA, PA, MA, FL, TN, NJ, GA, AZ, IL, OH, OK, WA, NY, NV, MO, MD, IN, TX, CO, RI, NC, KY, MT, VI, GA, KS, MI, AK, ID, SD, UT and internationally to Canada.
Quantity14959 kits
Recall ReasonFirm unable to confirm that the tenaculum devices were produced in accordance with required design and manufacturing standards.
Device Classification20211027
Device Code InfoPart Number: 935K
Center Classification Date20211016
Recall Initiation Date20210910
Recalling FirmStradis Medical, LLC dba Stradis Healthcare
Initial Notification Letter
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