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U.S. Department of Health and Human Services

Class 3 Device Recall Cordis

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 Class 3 Device Recall Cordissee related information
Date Initiated by FirmAugust 29, 2003
Date PostedJuly 20, 2004
Recall Status1 Terminated 3 on May 07, 2004
Recall NumberZ-0565-04
Recall Event ID 27138
Product Classification Forceps, General & Plastic Surgery - Product Code GEN
ProductCordis Biopsy Forceps 7F 104 cm Standard, Product Number 504300L
Code Information Lot Number 70403255
FEI Number 1016427
Recalling Firm/
Manufacturer		 Cordis Corporation
14201 N.W. 60th Ave
Miami Lakes FL 33014
For Additional Information ContactHal Baden
786-313-2365
Manufacturer Reason
for Recall		Some devices may have an incorrect inner label which shows Product # 504302L with a length of 50cm, while the outer label is correctly labeled as Product # 504300L with the length of 104cm.
FDA Determined
Cause 2		Other
ActionThe firm initially sent Cordis representatives to visit all 21 domestic accounts the week of August 25, 2003. Follow-up Recall notificaiton Letters were sent to each account discussing the problem and informing them that a Cordis Representative has been at their location and inspected their product for misbranded devices. In 18 cases the letter stated that NO mislabeled product was found but in three other cases they were told that mislabeled product was found and recovered. These follow-up letters to the visits were sent out on August 29, 2003. A similar inspection was performed by Cordis Representatives for International Accounts and the Recall Notification was sent to the International Accounts on 8/29/2003.
Quantity in Commerce220
DistributionThe devices were distributed to 21 domestic hospital accounts in MI, OK, FL, TN, NY, IN, VA, NC, WI, GA, IA, NE, CA. Also product was distributed to International Distributors in the Netherlands, Canada and Mexico.
Total Product Life CycleTPLC 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.
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