Z-0776-2021 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- January 13, 2021
- Initiation Date
- December 1, 2020
- Termination Date
- July 14, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8 units
Product Description
Hot AXIOS Stent and Electrocautery - Enhanced Delivery System 10mm x10mm (OUS) UPN: M00553540 - Product Usage: The stent is intended for implantation up to 60 days and should be removed upon confirmation of pseudocyst or walled-off necrosis resolution.
Reason for Recall
The rotating luer fitting at the distal end of the delivery system handle may become detached from the nose of the delivery during device preparation, stent delivery or use, resulting in delay or procedure or risk of peritonitis developing from leakage of enteric, pseudocyst, or biliary contents into the peritoneal cavity
Distribution Pattern
US Nationwide distribution - Foreign: TBD.
Code Information
Lot Number: 26130517 Exp. Date Range: 10/5/2022 GTIN: 08714729904564