Beacon EUS Access System Preloaded Access 135degree recall
Beacon EUS Access System Preloaded Access 135degree Needle sterile, single-use, endoscopic ultrasound device consisting of a sharp stylet and an…
Why was Beacon EUS Access System Preloaded Access 135degree recalled?
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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Model # DSA-135-01 UDI: 10884521663527 Lot #: F2510371X, F2510861X, F2512341X, F2512383X, F2512493X, F2513453X
- Product
- Beacon EUS Access System Preloaded Access 135degree Needle sterile, single-use, endoscopic ultrasound device consisting of a sharp stylet and an…
- Recalling firm
- Covidien Llc
- Quantity
- 269 units
- Distribution
- world wide distribution
- Recall date
- August 12, 2020
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)