This medical device is packaged in an inner Tyvek pouch and then in an outer carton. The outer carton is labeled as Cordis PRECISE RX Nitinol Stent Transhepatic Biliary System Cordis a Johnson n Johnson Company ENDOVASCULAR Cat. No. Lot No. Use By. The inner pouch is similarly labled.
FDA Recall Z-0909-04 · Posted 2004-07-20
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Recalling FirmCordis Corporation
Recall StatusTerminated
Product CodeFGE
Date Initiated2004-01-13
Date Terminated2010-08-30
Product Quantity7815
Reason for Recall
Air may be introduced into this Stent system when used with certain size acessory devices.
Firm Action
On Jan. 13, 2004 Cordis initiated Sales Representative visits to accounts to provide enhanced Instructions for Use to prevent the air introduction problem which was followed by a Recall Letter to each account providing corrective Instructions for Use on March 29, 2004. Another letter issued on May 4, 2004 recalling the earlier March 29, 2004 letter and modified Instructions for Use, instructing consignees/physicians to only use the device in the biliary tree or liver as indicated in the lableling.
Root Cause
Other
Distribution Pattern
Product was distributed to 415 domestic hospital accounts nationwide and to two related international distributores in Isreal and the Netherlands.
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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