Recall Z-2292-2021 ยท DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
W L Gore & Associates, Inc.
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
| Date | May 12, 2021 |
| Status | Open, Classified |
| 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. |
| Root cause | Under Investigation by firm |
| Action | On May 10, 2021, Gore issued a "Medical Device Recall" notification to affected customers via USPS. In addition to informing consignees about the recall, the firm asked consignees to take the following actions: 1. Identify and return any unused devices within the scope of this voluntary recall. 2. Please complete and sign the enclosed CUSTOMER RETURN FORM and return to FieldActionTeam@wlgore.com within 2 weeks of receipt of this notification. 3. Please share this letter with others in your hospital or clinic as appropriate. Please transfer this notice to other organization(s) as appropriate |
| Distribution | US: NE, DC, MA, KY, IL, WA, MD, CA, AZ, GA OUS: Canada, Brazil, Europe, Saudi Arabia |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K062161 | GORE PROPATEN VASCULAR GRAFT W. L. Gore & Associates, Inc., Nov 9, 2006 |