The Recall Desk

FDA (Devices) recall action 88245

W L Gore & Associates, Inc. recalled 2 products on 2021-08-25

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2021-08-25
Critical
0
Units
—

Why these products were recalled

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.

The agency’s own wording, quoted from the enforcement report.

States named across these recalls

1–2 of 2

  • HighFDA (Devices)··2021-08-25

    Gore Propaten Vascular Graft Pediatric Shunt Diameter Labeling Error

    W L Gore is recalling certain Gore Propaten Vascular Grafts for pediatric shunts due to incorrect diameter labeling. Grafts labeled as 5 mm may actually be 6 mm and vice versa.

    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
    Category
    Distribution
    10 states
  • HighFDA (Devices)··2021-08-25

    Gore Propaten Vascular Graft Pediatric Shunt Dimension Labeling Error Recall

    W L Gore & Associates is recalling Gore Propaten Vascular Grafts for pediatric shunts due to incorrect diameter labeling: grafts with 6mm inner diameter are labeled 5mm, and those with 5mm diameter are labeled 6mm.

    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
    Category
    Distribution
    10 states