—#88847

Product

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

FDA product code: DYB — Introducer, Catheter
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K945616
Affected lot / code info: Catalog 402656X Lot # 15076369. Catalog 504606X Lot # 15075717. Catalog 504656X Lot # 15076362, 15076363, and 15076364.

Why it was recalled

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.

Root cause (FDA determination)

Package design/selection

Action the firm took

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.

Recalling firm

Firm: Cordis Corporation
Address: 14201 Nw 60th Ave, Miami Lakes, Florida 33014-2802

Distribution

Distribution pattern: Nationwide.

Timeline

Recall initiated: 2010-01-28
Posted by FDA: 2010-04-20
Terminated: 2012-07-27
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #88847. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.