Recall Z-2292-2021— W L Gore & Associates, Inc.

Name: FDA recall Z-2292-2021
Creator: U.S. Food and Drug Administration
Published: 2021-05-12

Class II · Ongoing

Class II FDA medical device recall by W L Gore & Associates, Inc., initiated 2021-05-12. It names one FDA 510(k) clearance: K062161. 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. Reason: 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..

Recalling firm: W L Gore & Associates, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2021-05-12
Firm location: Flagstaff, AZ, United States

510(k) clearances named in this recall

1 on FDA's record

K062161 — GORE PROPATEN VASCULAR GRAFTW. L. Gore & Associates, Inc.·cleared 2006-11-09

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.