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Terminated

Cordis, AVANTI+ Introducer, STERILE EO, For one use only. Catalog 402656X Lot # 15076369. Catalog 504606X Lot # 15075717. Catalog 504656X Lot # 15076362, 15076363, 15076364.

FDA Recall Z-1421-2010 · Posted 2010-04-20

Recalling FirmCordis Corporation
Recall StatusTerminated
Product CodeDYB
Date Initiated2010-01-28
Date Terminated2012-07-27
Product Quantity1850 units

Reason for Recall

Sterility compromised: Cordis found a pin hole in one of the packaging tray cavities.On January 28, 2010 Cordis Corporation initiated a recall on their AVANTI + Introducer. During routine inspection, a visual irregularity was detected in packing trays.

Firm Action

Cordis initiated the recall January 28, 2010. (The packets were sent overnight on January 28, 2010, with first receipt by customers January 29, 2010.) Immediate corrective action was taken through an inspection and removal of all affected products.

Root Cause

Package design/selection

Distribution Pattern

Nationwide.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K945616CORDIS AVANTI CATHETER SHEATH INTRODUCERCordis Corp. · 1995-03-29

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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