Z-2768-2020 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- August 12, 2020
- Initiation Date
- June 26, 2020
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 375 units
Product Description
Beacon EUS Access System Preloaded Access 90degree Needle sterile, single-use, endoscopic ultrasound device consisting of a sharp stylet and an 18.5-gauge, echo-enhanced, tip-shaped, nitinol cannula intended to pierce tissue and then act as an access channel to facilitate guidewire placement to locations of the gastrointestinal tract.
Reason for Recall
This voluntary recall is being conducted following three customer reports of the device cannula detaching during a procedure. In one case, the detached cannula was not retrieved during the procedure. Potential risks associated with a detached cannula include delay in treatment, biliary leak, pain and retained device fragments.
Distribution Pattern
world wide distribution
Code Information
Model # DSA-090-01 UDI: 10884521722583 Lot #: F2510370X, F2510900X, F2512340X, F2512378X, F2512492X, F2512620X, F2513452X