Recall Z-0938-2011 ยท DQY Catheter, Percutaneous
Flowcardia Inc.
Crosser 14S Catheter, Catalog/REF CRU14S, Lot number 5053 manufactured by Flowcardia Inc, Sunnyvale, CA Intended use: Catheter for use in surgery.
| Date | Jan 24, 2011 (initiated Jan 9, 2009) |
| Status | Terminated |
| Reason | 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 | 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 |
| Quantity | 35 units |
| Distribution | Nationwide distribution: CA, NJ, LA, TX, GA, MI and CO. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K072776 | THE CROSSER SYSTEM Flowcardia, Inc., Dec 7, 2007 |