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W L Gore & Associates, Inc. Recall 88683

Description: REF/Catalogue Number GSX0025A, GORE CARDIOFORM SEPTAL OCCLUDER 25 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132631025 *Not distributed within the US

W L Gore & Associates, Inc. Recall 88683 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0166-2022
Event ID88683
Event DescriptionREF/Catalogue Number GSX0025A, GORE CARDIOFORM SEPTAL OCCLUDER 25 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132631025 *Not distributed within the US
Product TypeDevices
DistributionUS: AL,AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN,MO,MS,MT,NC, ND, NE, NH, NJ, NM,NV,NY,OH,OK,OR,PA,SC,SD,TN,TX,UT,VA,VT,WA,WI, WV OUS: AUS, AUT, CAN, CHE, DEU, DNK, ESP, FRA, GBR, GRC, IRL, ITA, MEX, NLD, NOR, PRT, SAU, SWE
Recall ReasonSeptal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiration date instead of 2 yrs.
Device Classification20211103
Device Code Infoserial numbers 22689696 through 23569078
Center Classification Date20211022
Recall Initiation Date20210902
Recalling FirmW L Gore & Associates, Inc.
Initial Notification Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
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