W L Gore & Associates, Inc.: 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.

Agency Publication Date: August 13, 2021

Affected Products

Product: Gore Propaten Vascular Graft configured for Pediatric Shunt, Diameter 5 mm, Length 10 cm, Rx Only, Sterile EO, for the following Reference numbers: HPT050010 UDI: (01)00733132606320 HPT050010A UDI: (01)00733132606337

Serial Numbers for HPT050010A: 6185494PP001, 6185494PP002, 6185494PP004, 6185494PP006, 6185494PP008, 6185494PP009, 6185494PP010, 6185494PP011, 6185494PP012, 6185495PP001, 6185495PP002, 6185495PP004, 6185495PP005, 6185495PP006, 6185495PP007, 6185495PP009, 6185495PP010, 6185495PP011, 6185495PP012, 6185495PP014 and Serial Numbers for HPT050010: 6185497PP001, 6185497PP005, 6185497PP006, 6185497PP007, 6185497PP008, 6185497PP009, 6185497PP010, 6185497PP011, 6185497PP012

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

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

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 88245

Status: Active

Manufacturer: W L Gore & Associates, Inc.

Manufactured In: United States

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Sources: FDA iRES · Raw API Response

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Affected Products