This device is labeled as Sterile and is packaged in a Tyvek pouch with the following labeling: PALMAZ Genesis TRANSHEPATIC BILIARY STENT on Aviator RX Delivery System REF Cat. No. Cordis ENDOVASCULAR Lot No. Use By Cordis Europa N.V. 9301 LJ Roden The Netherlands STERILE Min. Guiding Catheter ID Nominal Pressure Rated Burst Pressure
FDA Recall Z-0567-04 · Posted 2004-07-20
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Recalling FirmCordis Corporation
Recall StatusTerminated
Product CodeMAF
Date Initiated2003-09-26
Date Terminated2009-10-05
Product Quantitytotal for both devices of 39,726
Reason for Recall
A packaging defect may compromise the device's sterility barrier.
Firm Action
The firm initially mailed letters to accounts on 9/26/2003 instructing them to quarantine the indicated products pending a visit from Cordis inspectors. This mailing was followed up by one of two methods: 1) some accounts were visited by a Cordis Inspector who inspected the product at the account, and removed any potentially discrepant product and put a green dot on product which passed inspection and could be used, and 2) the remainder of the accounts were visited by Cordis Sales Representatives, in which case all product was removed from the account and returned to Cordis for inspection. Product passing Cordis inspection had a green dot put on the label and was redistributed. A representative of the account, and the inspector or sales representative signed an Acknowledgement form which in kept by Cordsi. This inspection process was completed by January 22, 2004.
Root Cause
Other
Distribution Pattern
Product was distributed nationwide to 1035 domestic hospital accounts no international, government or military accounts.
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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