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U.S. Department of Health and Human Services

Class 1 Device Recall SlipCath Beacon Tip Catheter

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  Class 1 Device Recall SlipCath Beacon Tip Catheter see related information
Date Initiated by Firm July 02, 2015
Date Posted August 05, 2015
Recall Status1 Terminated 3 on September 02, 2017
Recall Number Z-2319-2015
Recall Event ID 71692
510(K)Number K122937  
Product Classification Catheter, intravascular, diagnostic - Product Code DQO
Product Slip-Cath Beacon Tip Catheter. Angiographic catheter.

For use in angiographic procedures as a conduit for the delivery of contrast media and can help physicians diagnose occlusion or stenosis. The catheters are designed for percutaneous introduction into the vascular system over an appropriately sized wire guide.
Code Information All lots of the following  Product numbers: SCBR4.0-35-150-P-NS-0,  SCBR4.0-35-65-P-NS-RC2,  SCBR4.0-38-100-P-NS-0,  SCBR4.0-38-100-P-NS-C2,  SCBR4.0-38-100-P-NS-DAV, SCBR4.0-38-100-P-NS-H1,  SCBR4.0-38-100-P-NS-HN4,  SCBR4.0-38-100-P-NS-JB1,  SCBR4.0-38-100-P-NS-JB2, SCBR4.0-38-100-P-NS-KMP,  SCBR4.0-38-100-P-NS-MAN,  SCBR4.0-38-100-P-NS-MPA,  SCBR4.0-38-100-P-NS-MPB, SCBR4.0-38-100-P-NS-SIM1,  SCBR4.0-38-100-P-NS-SIM2,  SCBR4.0-38-100-P-NS-SIM3,  SCBR4.0-38-100-P-NS-VERT, SCBR4.0-38-125-P-NS-0,  SCBR4.0-38-125-P-NS-DAV,  SCBR4.0-38-125-P-NS-JB1,  SCBR4.0-38-125-P-NS-SIM1, SCBR4.0-38-125-P-NS-SIM2,  SCBR4.0-38-125-P-NS-TEGT,  SCBR4.0-38-125-P-NS-VERT,  SCBR4.0-38-125-P-NS-VTK, SCBR4.0-38-40-P-NS-KMP,  SCBR4.0-38-65-P-NS-0,  SCBR4.0-38-65-P-NS-C2,  SCBR4.0-38-65-P-NS-KMP,  SCBR4.0-38-65-P-NS-MPA, SCBR4.0-38-65-P-NS-RIM,  SCBR4.0-38-65-P-NS-TC,  SCBR4.0-38-65-P-NS-TC-BNK,  SCBR4.0-38-65-P-NS-VERT, SCBR4.0-38-80-P-NS-RH,  SCBR4.0-38-80-P-NS-VS,  SCBR4.0-38-80-P-NS-VS1,  SCBR4.0-38-80-P-NS-VS2,  SCBR4.0-38-80-P-NS-VS3, SCBR4.1-35-65-P-NS-C2,  SCBR4.1-35-75-P-NS-CHG2.5, SCBR5.0-35-90-P-NS-RUC
Recalling Firm/
Manufacturer		 Cook Inc.
750 N Daniels Way
Bloomington IN 47404-9120
For Additional Information Contact Cook Medical Customer Relations
812-339-2235
Manufacturer Reason
for Recall		 Reports of catheter tip splits and or separation. Loss of device function, medical intervention to retrieve separated segment, or complications resulting from separated tip occluding blood flow to end organs may result.
FDA Determined
Cause 2		 Component design/selection
Action Cook Medical sent an Urgent Medical Device Recall letter dated July 2, 2015, to all affected customers. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification and instructions for returning the affected product. All customers were notified via courier. Customers with questions were instructed to contact Cook Medical Customer Relations at (800) 457-4500 or (812) 339-2235. Firm issued press release 8/3/2015.
Quantity in Commerce 248167
Distribution Worldwide Distribution - US (nationwide including Puerto Rico and US Virgin Islands), Algeria, Antigua, Armenia, Austria, Australia, Bahamas, Belgium, Bangladesh, Bulgaria, Bahrain, Brazil, Brunei Darussalam, Canada, Canary Islands, Chile, China, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Dominican Republic, Egypt, El Salvador, Finland, France, French Polynesia, Georgia, Germany, Ghana, Great Britain, Greece Guadeloupe, Hong Kong, Hungary, Iceland, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Jersey, Jordan, Kuwait, Kazakhstan, Republic of Korea, Kuwait, Lebanon, Lithuania, Luxemburg, Latvia, Libya, Macau, Malaysia, Malta, Martinique, Mexico, Mongolia, Morocco, Netherlands, Netherlands Antilles, New Caledonia, New Zealand, Nicaragua, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Sri Lanka, Sweden, Switzerland, Spain, Taiwan, Thailand, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, and Vietnam.
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 = DQO and Original Applicant = COOK, INC.
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