Recalls / —
—#103267
Product
Habib, 4x Kit, Bipolar Resection Device RITA (Radiofrequency Ablation Devices). AngioDynamics, Inc., One Horizon Way, Manchester, GA 30816. Intended to be used to assist in coagulation of tissue during intraoperative surgical procedures.
- FDA product code
- GEI — Electrosurgical, Cutting & Coagulation & Accessories
- Device class
- Class 2
- Medical specialty
- General, Plastic Surgery
- 510(k) numbers
- K051420
- Affected lot / code info
- Catalog number: 4401L, Batch number: 511829, 511830, 513063 513519 and 513789.
Why it was recalled
The labeling contains errors which result in the products being misbranded
Root cause (FDA determination)
Labeling False and Misleading
Action the firm took
AngioDynamics, Inc. sent out a "Medical Device Recall" letter dated August 30, 2010 to all affected customers. The letter included; products affected, problem and asked them to return the product back to AngioDynamics. Customers were asked to fill out and return the included Recall Reply Form. For question on this recall contact AngioDynamics at (800) 772-6446.
Recalling firm
- Firm
- Angiodynamics, INC
- Address
- 1 Horizon Way, Manchester, Georgia 31816-1749
Distribution
- Distribution pattern
- Worldwide Distribution: (USA) Nationwide distribution and the countries of Austria, China, Denmark, Egypt, France Germany, India, Italy, Latvia, Netherlands, Poland, Russian Federation, South Africa, Switzerland and the United Kingdom
Timeline
- Recall initiated
- 2010-08-30
- Posted by FDA
- 2011-08-24
- Terminated
- 2012-03-12
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #103267. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.