W L Gore & Associates, Inc. Recall 88721
Description: Heparin, GORE VIABAHN VBX, BALLOON EXPANDABLE ENDOPROTHESIS, REF BXAL085902E, 8 MM X 59 MM 8 Fr, LARGE BALLOON EXPANDLBE, Nominal Stent Diameter 8 mm, Max Post-Dilated Stent Diameter 16 mm, UDI:
W L Gore & Associates, Inc. Recall 88721 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0077-2022 |
| Event ID | 88721 |
| Event Description | Heparin, GORE VIABAHN VBX, BALLOON EXPANDABLE ENDOPROTHESIS, REF BXAL085902E, 8 MM X 59 MM 8 Fr, LARGE BALLOON EXPANDLBE, Nominal Stent Diameter 8 mm, Max Post-Dilated Stent Diameter 16 mm, UDI: |
| Product Type | Devices |
| Distribution | International distribution to the countries of Italy & Lebanon. |
| Quantity | 2 units |
| Recall Reason | Incorrect labeling, specifically, expandable endoprosthesis labeled as 8 mm x 59mm x 135 cm, however may contain a 9mm x 29 mm x 135 cm device. |
| Device Classification | 20211020 |
| Device Code Info | Serial Numbers: 22753580 |
| Center Classification Date | 20211008 |
| Recall Initiation Date | 20210907 |
| Recalling Firm | W L Gore & Associates, Inc. |
| Initial Notification | |
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