medical Class II Updated 2021-08-25

W L Gore & Associates, Inc. recalls Gore Propaten Vascular Graft configured for Pediatric Shunt,

Recalled Product

Gore Propaten Vascular Graft configured for Pediatric Shunt, Diameter 6 mm, Length 15 cm, Rx Only, Sterile EO, for the following Reference numbers: HPT060015 UDI: (01)00733132606368 HPT060015A UDI: (01)00733132606375

Hazard / Issue

Vascular Grafts containing an inner diameter of 6 mm may be incorrectly labeled as 5 mm and Vascular Grafts containing an inner diameter of 5 mm are incorrectly labeled as 6 mm.

Issued by

FDA

Affected States: NE, DC, MA, KY, IL, WA, MD, CA, AZ, GA

Lot/Code Info: Serial Number for HPT060015A: 6185496PP001 and Serial Numbers for HPT060015: 6185502PP001, 6185502PP002, 6185502PP003, 6185502PP004, 6185502PP006, 6185502PP007, 6185502PP009, 6185502PP010, 6185503PP001, 6185503PP002, 6185503PP004, 6185503PP005, 6185503PP006, 6185503PP007, 6185503PP008, 6185503PP009, 6185503PP010

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