Product is Cordis Brite Tip Catheter Sheath Introducer (4, 7, 8, 9, 10 and 11French sizes only).
FDA Recall Z-0941-03 · Posted 2003-06-12
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Recalling FirmCordis Corporation
Recall StatusTerminated
Product CodeDYB
Date Initiated2003-05-05
Date Terminated2008-11-19
Product Quantity49,022
Reason for Recall
Reports of broken or separated tips of the catheter sheath introducers.
Firm Action
Cordis provided their national sales force with a recall package for each customer for that representative's area for visits on 5/5/2003. The sales reps were to visit each hospital/medical facitliy to present them with the Recall Letter (dated 5/5/2003) and also a Question and Answer Sheet. The sales rep will search and quarantine for return all involved products in the customers inventory. The sales representative and customer will fill out and sign response forms and return them and the recalled product to 'Cordis Returned Goods' in Miami Lakes, FL. Due to delays in completing the visits the firm sent the same Recall Letter to all accounts that had not been visited yet on 5/30/03. In addition the Sales Reps will still visit the remaining accounts and recover recalled product.
Root Cause
Other
Distribution Pattern
Product was distributed nationwide to 1057 hospital/medical facitilites including 33 military/VA hospitals. In addition recalled product was distributed to 7 related International Distributors in The Netherlands, Brazil, Canada, Chile, Columbia, Mexico and Venezuela.
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.
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