Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

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 Recall Z-0637-2007 · Posted 2007-03-16

Recalling FirmCook, Inc.
Recall StatusTerminated
Product CodeFOZ
Date Initiated2007-01-02
Date Terminated2007-12-05
Product Quantity100

Reason for Recall

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

Firm Action

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

Root Cause

Other

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K950118ABRM CATHETERCook, Inc. · 1996-02-08

Official Source

View FDA Recall →

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

↑