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U.S. Department of Health and Human Services

Class 2 Device Recall Cordis Smart Control

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  Class 2 Device Recall Cordis Smart Control see related information
Date Initiated by Firm February 03, 2003
Date Posted April 02, 2003
Recall Status1 Terminated 3 on September 08, 2010
Recall Number Z-0707-03
Recall Event ID 25712
510(K)Number K021898  K023217  
Product Classification Stents, Drains And Dilators For The Biliary Ducts - Product Code FGE
Product The device is Labeled as SMART Control TRANSHEPATIC BILIARY STENT REF (PRODUCT NUMBER LISTED), VARIOUS LABELED SIZES . and lot numbers.
Product is packed in a Tyvek pouch and further packed into a shelf carton.
Product Numbers: C06020SB, C06020MB, C06030SB, C06030MB, C06040SB, C06040MB, C06060SB, CO6060MB, C06080SB, C06080MB, C06100SB, C06100MB, C07020SB, C07020MB, C07030SB, C07030MB, C07040SB, C07040MB, C07060SB, C07060MB, C07080SB, C07080MB, C07100SB, CO7100MB, C08020SB, C08020MB, CO8030SB, C08030MB, C08040SB, C08040MB, C08060SB, C08060MB, C08080SB, C08080MB, C08100SB, C08100MB, C09020SB, C09020MB, C09030SB, C09030MB, C09040SB, C09040MB, C09060SB, C09060MB, C09080SB, C09080NB, C10020SB, C10020MB, C10030SB, C10030MB, C10040SB, C10040MB, C10060SB, C10060MB, C10080SB, C10080MB.
Product number related to dimension as follows:
C06020SB 6mm x 20mm x 80cm
C06020MB 6mm x 20mm x 120cm
C06030SB 6mm x 30mm x 80cm
C06030MB 6mm x 30mm x 120cm
C06040SB 6mm x 40mm x 80cm
C06040MB 6mm x 40mm x 120cm
C06060SB 6mm x 60mm x 80cm
C06060MB 6mm x 60mm x 120cm
C06080SB 6mm x 80mm x 80cm
C06080MB 6mm x 80mm x 120cm
C06100SB 6mm x 100mm x 80cm
C06100MB 6mm x 100mm x 120cm
C07020SB 7mm x 20mm x 80cm
C07020MB 7mm x 20mm x 120cm
C07030SB 7mm x 30mm x 80cm
C07030MB 7mm x 30mm x 120cm
C07040SB 7mm x 40mm x 80cm
C07040MB 7mm x 40mm x 120cm
C07060SB 7mm x 60mm x 80cm
C07060MB 7mm x 60mm x 120cm
C07080SB 7mm x 80mm x 80cm
C07080MB 7mm x 80mm x 120cm
C07100SB 7mm x 100mm x 80cm
C07100MB 7mm x 100mm x 120cm
C08020SB 8mm x 20mm x 80cm
C08020MB 8mm x 20mm x 120cm
C08030SB 8mm x 30mm x 80cm
C08030MB 8mm x 30mm x 120cm
C08040SB 8mm x 40mm x 80cm
C08040MB 8mm x 40mm x 120cm
C08060SB 8mm x 60mm x 80cm
C08060MB 8mm x 60mm x 120cm
C08080SB 8mm x 80mm x 80cm
C08080MB 8mm x 80mm x 120cm
C08100SB 8mm x 100mm x 80cm
C08100MB 8mm x 100mm x 120cm
C09020SB 9mm x 20mm x 80cm
C09020MB 9mm x 20mm x 120cm
C09030SB 9mm x 30mm x 80cm
C09030MB 9mm x 30mm x 120cm
C09040SB 9mm x 40mm x 80cm
C09040MB 9mm x 40mm x 120cm
C09060SB 9mm x 60mm x 80cm
C09060MB 9mm x 60mm x 120cm
C09080SB 9mm x 80mm x 80cm
C09080MB 9mm x 80mm x 120cm
C10020SB 10mm x 20mm x 80cm
C10020MB 10mm x 20mm x 120cm
C10030SB 10mm x 30mm x 80cm
C10030MB 10mm x 30mm x 120cm
C10040SB 10mm x 40mm x 80cm
C10040MB 10mm x 40mm x 120cm
C10060SB 10mm x 60mm x 80cm
C10060MB 10mm x 60mm x 120cm
C10080SB 10mm x 80mm x 80cm
C10080MB 10mm x 80mm x 120cm
Code Information All lot numbers for the referenced product numbers.
Recalling Firm/
Manufacturer		 Cordis Corporation
14201 NW 60th Ave
Miami Lakes FL 33014
For Additional Information Contact Dennis Donohoe, MD
786-313-2955
Manufacturer Reason
for Recall		 The SMART Control Stent Delivery System may not fully deploy or be difficult to deploy under certain circumstances.
FDA Determined
Cause 2		 Other
Action The firm sent via Federal Express Overnight delivery, a notification letter entitled 'IMPORTANT PRODUCT INFORMATION ALERT' dated 2/3/2003 to all user hosptial accounts. The letter warns them of the possibility of partial deployment and how to avoid it. There is no request to stop using or to return the product. The firm considers the action a 'Safety Alert'.
Quantity in Commerce 32000
Distribution Product was distributed to 1141 user/medical facilities nationwide.
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.
510(K) Database 510(K)s with Product Code = FGE and Original Applicant = CORDIS CORP.
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