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Class 2 Device Recall Beacon EUS Access System Preloaded Access 90degree Needle |
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Date Initiated by Firm |
June 26, 2020 |
Date Posted |
August 05, 2020 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-2768-2020 |
Recall Event ID |
86001 |
510(K)Number |
K180037
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Product Classification |
Biopsy needle - Product Code FCG
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Product |
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. |
Code Information |
Model # DSA-090-01 UDI: 10884521722583 Lot #: F2510370X, F2510900X, F2512340X, F2512378X, F2512492X, F2512620X, F2513452X |
Recalling Firm/ Manufacturer |
Covidien Llc 15 Hampshire St Mansfield MA 02048-1113
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For Additional Information Contact |
770-662-0510
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Manufacturer 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.
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FDA Determined Cause 2 |
Under Investigation by firm |
Action |
Medtronic sent a letter notification to customers dated July 06, 2020 recalling effected lots of product. This letter instructed customers to discontinue use of the product and quarantine effected inventory. Customers were also instructed to return effected product and complete recall response forms accordingly. |
Quantity in Commerce |
375 units |
Distribution |
world wide distribution |
Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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510(K) Database |
510(K)s with Product Code = FCG and Original Applicant = Covidien llc
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