—#34142

Product

Vistabritetip IG Introducer, Introducer Guide. Labeled as sterile, sterilized with ethylene oxide gas. For single use only. Catalog number 4038553S

FDA product code: DQY — Catheter, Percutaneous
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K001136
Affected lot / code info: Lot # L0104244

Why it was recalled

The product is labeled as Straight Catheter but the package contains Contralateral Guide shaped Catheters.

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

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

Distribution

Distribution pattern: Distributed in FL, OK, SC, and KS in the US. Internationaly to South Africa and the Netherlands.

Timeline

Recall initiated: 2004-05-05
Posted by FDA: 2005-03-10
Terminated: 2008-11-21
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #34142. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.