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RITA Starburst MRI SemiFlex (3-5 cm Diameter/25cm Length)… recallZ-0754-2007 · Rita Medical Systems, Inc. · initiated Apr 3, 2007

Terminated All recalls posted in April 2007

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Rita Medical Systems, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

The product may have a cracked tray which can compromise the sterility of the product.

FDA root cause category: Other

What the company is doing

Notification by letter of the AngioDynamics, Inc. sales force and the domestic and international distributors began on April 2, 2007. They were asked to return all affected devices to the Manchester, GA division of AngioDynamics, Inc. A reply form was attached to be completed and returned via fax to AngioDynamics.

Recall details

Recall number
Z-0754-2007
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Apr 3, 2007
Posted by the FDA
Apr 19, 2007
Recalling firm
Rita Medical Systems, Inc.
Quantity
2021 devices
Product code
GEI
FDA submissions
K992693
Distribution
Worldwide, including USA, Austria, Canada, Croatia, Denmark, Egypt, Estonia, France, Finland, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Japan, Latvia, Netherlands, Norway, Poland, Republic of Ireland, Romania, Russia, Saudi Arabia, Singapore, Solomon Islands, South Africa, Spain, Switzerland, UK, and United Arab Emirates.

Product description

RITA Starburst MRI SemiFlex (3-5 cm Diameter/25cm Length), Electro-surgical Device, Manufactured by: RITA Medical Systems, Inc., One Horizon Way, Manchester, GA 31816

Code information (models, lots, serial numbers)

Part number: 700-102615, Lot number: 22445, 24657, 24772, 24557, 24824, 24921, 25126, 25360, 25361, 25431, 25432, 25554, 25601, 25555, 25644, 25755, 25645, 25756, 25815, 25816, 25860, 25859, 25947, 25948, 26153, 26239, 26312, 26466, 25977, 25978, 26240, 26311, 26467, 26564, 26580, 26587, 26588, 26672, 26673, 26730, 26940, 26941, 26994, 27071, 27165, 27179, 27256, 27358, 27408, 27407, 27409, 27444, 27562, 27594, 27719, 27720, 27811, 27875, 27877, 27961, 27962, 27968, 28091, 28098, 28257, 28322, 28440, 28441, 28468, 28525, 28526, 28560, 28638, 28714, 28639, 28719, 28906, 28881, 28971, 28972, 29044, 29113, 29158, 29159, 29256, 29340, 29548, 29045, 29667, 29856 & 29969

Other devices under the same FDA submission

5 devices cleared under K992693 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 37742).

Sources and updates

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