Crosser 14S Catheter, Catalog/REF CRU14S, Lot number 5053 manufactured by Flowcardia Inc, Sunnyvale, CA Intended use: Ca

FDA device recall Z-0938-2011 · posted 2011-01-24 · Terminated

Recall details

Recalling firm

Flowcardia Inc.

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.

Action taken

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.

Root cause

Employee error

Status

Terminated

Product code

DQY

Quantity affected

35 units

Distribution

Nationwide distribution: CA, NJ, LA, TX, GA, MI and CO.

Date initiated

2009-01-09

Date posted

2011-01-24

Date terminated

2011-01-25

Location

Sunnyvale, CA

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