Z-3279-2024 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- October 2, 2024
- Initiation Date
- August 1, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 507 units
Product Description
WALLFLEX ESOPHAGEAL FC 23/28MMX12CM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas Material Number (UPN): M00516740
Reason for Recall
WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of APAC, Canada, EMEA, LATAM.
Code Information
GTIN: 08714729778073 Lot Numbers: 32771050, 32771051, 32789719, 32790020, 32827713, 32837013, 32837014, 32846903, 32856378, 32875122, 32876614, 32888839 32906418, 32914770, 32919349, 32927196, 32928279, 32938993, 33014831, 33038108, 33101459, 33102100, 33119729, 33137310 33137311, 33137312, 33145979, 33176328, 33218760, 33256094, 33266648