—#49916

Product

COOK Triple Lumen Central Venous Catheter Tray with Cook Spectrum Glide Antimicrobial Catheter with EZ--Pass Hydrophilic Coating: Reorder Number C-UTLMY-701J-RSC-ABRM-HC-FST-A.

FDA product code: FOZ — Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K950118
Affected lot / code info: Lots 1794998 and 1793611.

Why it was recalled

These catheters do not include the proximal sidehole as required by the specification.

Root cause (FDA determination)

Other

Action the firm took

Consignees were notified by phone on 1/2/07 and instructed to return the product.

Recalling firm

Firm: Cook, Inc.
Address: 750 Daniels Way, Bloomington, Indiana 47404-9120

Distribution

Distribution pattern: Nationwide, including the states of Florida, Louisiana, Maine, Massachusetts, Minnesota, Missouri, New Jersey and North Carolina.

Timeline

Recall initiated: 2007-01-02
Posted by FDA: 2007-03-16
Terminated: 2007-12-05
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #49916. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.