Vistabritetip IG Introducer, Introducer Guide. Labeled as sterile, sterilized with ethylene oxide gas. For single use only. Catalog number 4038553S
FDA Recall Z-0588-05 · Posted 2005-03-10
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Recalling FirmCordis Corporation
Recall StatusTerminated
Product CodeDQY
Date Initiated2004-05-05
Date Terminated2008-11-21
Product Quantity40
Reason for Recall
The product is labeled as Straight Catheter but the package contains Contralateral Guide shaped Catheters.
Firm Action
A recall letter dated 04/30/2004 was sent to the consignees, instructing them to discontinue using the product and informed them that a Cordis representive would remove any unit in their possesion.
Root Cause
Other
Distribution Pattern
Distributed in FL, OK, SC, and KS in the US. Internationaly to South Africa 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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