Z-0938-2011

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

Name: Z-0938-2011 Crosser 14S Catheter, Catalog/REF CRU14S, Lot number 5053 manufactured by Flowcardia Inc, Sunnyvale, CA
Creator: Flowcardia Inc.
Published: 2009-01-09
License: https://open.fda.gov/license/

Flowcardia, Inc. / initiated 2009-01-09 / Terminated / root cause: manufacturing process

FDA source

Flowcardia Inc. began a recall of Crosser 14S Catheter, Catalog/REF CRU14S, Lot number 5053 manufactured by Flowcardia Inc, Sunnyvale, CA Intended use: Catheter for use in surgery on 2009-01-09. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0938-2011
Status: Terminated
Initiated: 2009-01-09
Posted: 2011-01-24
Terminated: 2011-01-25
Recalling firm: Flowcardia, Inc.
Product: Crosser 14S Catheter, Catalog/REF CRU14S, Lot number 5053 manufactured by Flowcardia Inc, Sunnyvale, CA Intended use: Catheter for use in surgery.
Product code: DQY Catheter, Percutaneous
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.
Root cause tag: manufacturing process
FDA root cause: 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 ([email protected]) 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.
Product codes and lots: labeled shelf life code 2011-12, lot number 5053

Product code DQY

K072776Class IIThe Crosser SystemFlowcardia, Inc. / cleared 2007-12-07

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)