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U.S. Department of Health and Human Services

Class 3 Device Recall

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  Class 3 Device Recall see related information
Date Initiated by Firm March 22, 2006
Date Posted May 06, 2006
Recall Status1 Terminated 3 on February 07, 2007
Recall Number Z-0843-06
Recall Event ID 34988
PMA Number P030006 
Product Classification System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy - Product Code MEQ
Product Prolieve¿ Thermodilatation¿ Kit, consisting of a Prolieve Thermodilatation Catheter, Prolieve Heat Exchanger cartridge and 500 ml bag of sterile water, Catalog # 880-8023, Material Number M0068808023, labeled in part *** Distributed by Boston Scientific Corporation, Natck, MA***Manufacturer: Celsion Corporation, Columbia, MD***.
Code Information Lot 600783 Exp Feb-08 Lot 600815 Exp Jan-08 Lot 600874 Exp Feb-08 Lot 600875 Exp Jan-08 Lot 600814 Exp Jan-08 Lot 600771 Exp Jan-08 Lot 600692 Exp Dec-07 Lot 600540 Exp Nov-07 Lot 600630 Exp Dec-07 Lot 600538 Exp Dec-07 Lot 600408 Exp Dec-07 Lot 600145 Exp Sep-07 Lot 600146 Exp Sep-07 Lot 600147 Exp Sep-07
Recalling Firm/
Manufacturer		 Celsion Corporation, Inc.
10220 Old Columbia Road
Suite L
Columbia MD 21046-2364
For Additional Information Contact Carolyn Finkle
410-290-5390
Manufacturer Reason
for Recall		 Surgical treatment kits containing medical device components were mislabeled with extended expiration dates.
FDA Determined
Cause 2		 Other
Action The recalling firm notified the contract distributor on 2/17/06 to cease shipments. The distributor subsequently notified accounts on 3/22/06 with lot and shipment specific recall letters. The letters advised that consignees discontinue use of the affected lots for return to the distributor. Consignees were requested to return the reply verification form enclosed.
Quantity in Commerce 1515 kits
Distribution Products were distributed to one distributor in MA and eight medical device users in MA, IL, NJ, FL, NY, CO, OH, and MI.
Total Product Life Cycle TPLC Device Report
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
PMA Database PMAs with Product Code = MEQ and Original Applicant = MEDIFOCUS, INC
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