medical Class II Updated 2021-11-03

W L Gore & Associates, Inc. recalls REF/Catalogue Number GSX0025A, GORE CARDIOFORM SEPTAL OCCLUD

Recalled Product

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

Hazard / Issue

Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiration date instead of 2 yrs.

Issued by

FDA

Affected States: 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
Lot/Code Info: serial numbers 22689696 through 23569078
View official government recall

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