Recall Z-2946-2024— W L Gore & Associates, Inc.
Class II · Ongoing
Class II FDA medical device recall by W L Gore & Associates, Inc., initiated 2024-07-01. FDA's recall record names no specific 510(k) clearance for this event. Product: Heparin, Gore Viabahn VBX, Balloon Expandable Endoprosthesis, for the following Reference numbers: United States: BXB055902C, BXB063902C, BXB065902C, BXB067902C, BXB073902C, BXB075902C, BXB077902C, BXB083902C, BXB085902C, BXB087902C, BXB093902C, BXB095902C, BXB097902C *For Clinical use.. Reason: Due to packaging defects, sterility assurance and heparin activity may be compromised..
- Recalling firm
- W L Gore & Associates, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-07-01
- Firm location
- Flagstaff, AZ, United States
Product description
Heparin, Gore Viabahn VBX, Balloon Expandable Endoprosthesis, for the following Reference numbers: United States: BXB055902C, BXB063902C, BXB065902C, BXB067902C, BXB073902C, BXB075902C, BXB077902C, BXB083902C, BXB085902C, BXB087902C, BXB093902C, BXB095902C, BXB097902C *For Clinical use.
Reason for recall
Due to packaging defects, sterility assurance and heparin activity may be compromised.
Data sourced from openFDA. This site is unofficial and independent of the FDA.