Z-0637-2007

COOK Triple Lumen Central Venous Catheter Tray with Cook Spectrum Glide Antimicrobial Catheter with EZ--Pass...

Name: Z-0637-2007 COOK Triple Lumen Central Venous Catheter Tray with Cook Spectrum Glide Antimicrobial Catheter with EZ--Pass...
Creator: Cook, Inc.
Published: 2007-01-02
License: https://open.fda.gov/license/

Cook Incorporated / initiated 2007-01-02 / Terminated

FDA source

Cook, Inc. began a recall of COOK Triple Lumen Central Venous Catheter Tray with Cook Spectrum Glide Antimicrobial Catheter with EZ--Pass Hydrophilic Coating: Reorder Number... on 2007-01-02. The reason FDA records is "These catheters do not include the proximal sidehole as required by the specification". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0637-2007
Status: Terminated
Initiated: 2007-01-02
Posted: 2007-03-16
Terminated: 2007-12-05
Recalling firm: Cook Incorporated
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.
Product code: FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Reason for recall: These catheters do not include the proximal sidehole as required by the specification.
FDA root cause: Other
Action: Consignees were notified by phone on 1/2/07 and instructed to return the product.
Quantity in commerce: 100
Distribution: Nationwide, including the states of Florida, Louisiana, Maine, Massachusetts, Minnesota, Missouri, New Jersey and North Carolina.
Product codes and lots: Lots 1794998 and 1793611.

Product code FOZ

K950118Class IIAbrm CatheterCook, Inc. / cleared 1996-02-08

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)