Crosser 14S Catheter, Catalog/REF CRU14S, Lot number 5053 manufactured by Flowcardia Inc, Sunnyvale, CA Intended use: Catheter for use in surgery.
FDA Recall Z-0938-2011 · Posted 2011-01-24
Recalling FirmFlowcardia Inc.
Recall StatusTerminated
Product CodeDQY
Date Initiated2009-01-09
Date Terminated2011-01-25
Product Quantity35 units
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.
Firm 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 ([email protected]) or telephone at 408-617-0352 x302. Alternatively you may contact customer service at 888-456-7286.
Root Cause
Employee error
Distribution Pattern
Nationwide distribution: CA, NJ, LA, TX, GA, MI and CO.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.