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U.S. Department of Health and Human Services

Class 1 Device Recall OptEase Vena Cava Filter

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 Class 1 Recall
OptEase Vena Cava Filter
see related information
Date Posted August 07, 2013
Recall Status1 Terminated on October 27, 2014
Recall Number Z-1887-2013
Recall Event ID 65482
Premarket Notification
510(K) Numbers
K034050  K091077 
Product Classification Filter, Intravascular, Cardiovascular - Product Code DTK
Product Cordis OPTEASE Retrieval Inferior Vena Cava (IVC) Filter***REF Cat. No.***466F220A and 466F220B***Vena Cava Filter and Introduction Kit***(BRITE TIP Catheter Sheath Introducer and Angiographic Vessel Dilator)***Cordis***a Johnson and Johnson Company***ENDOVASCULAR*** Label No. SB 10247519.2/***LB466F220AO.5***omoraoro/2012.050794***Do not resterilize***. Product Usage: The OPTEASE Vena Cava Filter is indicated for use in the prevention of recurrent pulmonary embolism (PE) via percutaneous placement in the vena cava in several situations: Pulmonary thromboembolism when anticoagulants are contraindicated; Failure of anticoagulant therapy for thromboembolic disease; Emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therapy are reduced and Chronic, recurrent pulmonary embolism where anticoagulant therapy has failed, or is contraindicated.
Code Information Model Numbers 466F220A and 466F220B.
Recalling Firm/
Manufacturer
Cordis Corporation
14201 Nw 60th Ave
Miami Lakes, Florida 33014-2802
For Additional Information Contact Hal Baden
786-313-2365
Manufacturer Reason
for Recall
Correction to provide clarification and additional labeling to minimize likelihood on implanting filter backwards.
FDA Determined
Cause 2
DESIGN: Labeling Design
Action Cordis Corporation sent an "URGENT Medical Device Correction" notification to their consignees in the US by letter dated April 3, 2013 and an e-mail was sent to the Canadian consignees. The letter identified the affected product, problem and actions to be taken. Consignees were instructed to read the description and recommendations sections carefully, then sign and return the enclosed Acknowledgement Form directly to Cordis to their fax number(908) 429-8287 or Scan and e-mail to MiamiQA@crdus.jnj.com. The letter states to pass on the notice to anyone in the consignees' facilities that need to be informed. Additionally, the notification request consignees to maintain awareness of this notification until the information has been incorporated in the Cordis OPTEASE Vena Cava Filter labeling. For questions related to the issue contact Cordis Endovascular Medical Information Line 877-338-4235.
Quantity in Commerce 33,000 units
Distribution Worldwide Distribution - USA Nationwide in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, Ny, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, including Hawaii and Puerto Rico and the countries of Canada & Panama
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = DTK and Original Applicant = CORDIS CORP., A JOHNSON & JOHNSON CO.
510(K)s with Product Code = DTK and Original Applicant = CORDIS CORPORATION
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