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U.S. Department of Health and Human Services

Class 2 Device Recall Crosser 14S Catheter

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  Class 2 Device Recall Crosser 14S Catheter see related information
Date Initiated by Firm January 09, 2009
Date Posted January 24, 2011
Recall Status1 Terminated 3 on January 25, 2011
Recall Number Z-0938-2011
Recall Event ID 50791
510(K)Number K072776  
Product Classification Catheter, percutaneous - Product Code DQY
Product Crosser 14S Catheter, Catalog/REF CRU14S, Lot number 5053 manufactured by Flowcardia Inc, Sunnyvale, CA

Intended use: Catheter for use in surgery.
Code Information labeled shelf life code 2011-12, lot number 5053
Recalling Firm/
Manufacturer		 Flowcardia Inc.
745 N Pastoria Ave
Sunnyvale CA 94085-2918
For Additional Information Contact Natalie Alfaro
408-617-0352
Manufacturer Reason
for Recall		 Mislabeled expiration date: Some units were mislabeled with a three year shelf life, but the product is validated only for a two year shelf life.
FDA Determined
Cause 2		 Employee error
Action The firm, FlowCardia, Inc., sent an "URGENT! Medical Device Recall" letter dated January 9, 2009 to all customers. The letter described the product, problem and action to be taken by the customers. The customers were instructed to return the product to FlowCardia, at the firms expense, for replacement and Confirm that this product has been used by completing and returning the attached fax document via fax to 408-616-0053. The customers were ask to please make an attempt to contact the customer service representatives, Operations specialist at 888-456-7286 or Vice President, Clinical, Quality & Regulatory Affairs at 408-617-0352 x302, within the next 30 days. Note: FlowCardia Sales, Clinical and Customer support will send notification via certified mail or traceable courier and track response. If you have any questions or need any additional information email (dmichaels@flowcardia.com) or telephone at 408-617-0352 x302. Alternatively you may contact customer service at 888-456-7286.
Quantity in Commerce 35 units
Distribution Nationwide distribution: CA, NJ, LA, TX, GA, MI and CO.
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 = DQY and Original Applicant = FLOWCARDIA, INC.
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