XLie with Tubing, 12 cm, Electrosurgical Device-RITA * Medical Systems, Inc. * StarBurst Xli enhanced with tubing set * * REF/Catalog: 700-103027 * 4-7 cm Diameter * 12cm Length * Sterile/R * RITA * Manufactured by: Rita Medical Systems, Inc., One Horizon Way, Manchester, Georgia 31816, USA
This recall has been terminated (originally issued May 31, 2006).
- Company
- Rita Medical Systems, Inc.
- Recall Initiated
- May 2, 2006
- Posted
- May 31, 2006
- Terminated
- February 5, 2008
- Recall Number
- Z-0888-06
- Quantity
- 19 units
- Firm Location
- Manchester, GA
- Official Source
- View on FDA website ↗
Reason for Recall
Misbranding; Product may have the wrong device handle which incorrectly identifies the product and also has incorrect deployment depth marker
Distribution
AL, AR, FL, LA, MA, NJ, NY, PA, TN, TX, UT and Italy
Lot / Code Info
Catalog number: 700-103027, Lot number 25952
Root Cause
Other
Action Taken
Consignees were first notified by telephone on 05/02/2006. A follow up letter was sent on 05/03/2006. The European Medical Device Agency, the Italian Competent Authority and British Standards Institution were notified by email on 05/03/2006.
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