Z-1135-2011

Central Venous Catheter Tray, Double Lumen Polyurethane, 4.0 Fr/ 8 cm, C-UDLMY-401J- CHILDRENS-HCT, G44038...

Name: Z-1135-2011 Central Venous Catheter Tray, Double Lumen Polyurethane, 4.0 Fr/ 8 cm, C-UDLMY-401J- CHILDRENS-HCT, G44038...
Creator: Cook, Inc.
Published: 2010-10-04
License: https://open.fda.gov/license/

Cook Incorporated / initiated 2010-10-04 / Terminated / root cause: manufacturing process

FDA source

Cook, Inc. began a recall of Central Venous Catheter Tray, Double Lumen Polyurethane, 4.0 Fr/ 8 cm, C-UDLMY-401J- CHILDRENS-HCT, G44038, Sterile, Cook Medical, Cook Incorporated... on 2010-10-04. The reason FDA records is "Cook, Inc. is recalling Single, Double, Triple, and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripherally Inserted Central Venous Catheter Trays. These kits and trays contain 0.9% Sodium...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1135-2011
Status: Terminated
Initiated: 2010-10-04
Posted: 2011-02-23
Terminated: 2011-06-21
Recalling firm: Cook Incorporated
Product: Central Venous Catheter Tray, Double Lumen Polyurethane, 4.0 Fr/ 8 cm, C-UDLMY-401J- CHILDRENS-HCT, G44038, Sterile, Cook Medical, Cook Incorporated, Bloomington, IN.
Product code: FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Reason for recall: Cook, Inc. is recalling Single, Double, Triple, and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripherally Inserted Central Venous Catheter Trays. These kits and trays contain 0.9% Sodium Chloride Injection USP 5 mL fill in 6 mL flush syringes that have been recalled by Excelsior Medical. During a routine test for syringe sterility, a possible integrity failure wa
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Cook, Inc. sent URGENT DEVICE RECALLS letters to its customers dated 10/4/2010. The letters asked customers to examine their inventory and notify Cook for product return. The letter included a response form.
Quantity in commerce: 51,473 total kits/trays
Distribution: Worldwide distribution: USA, Chile, Colombia, Panama, Barbados, Canada, Guatemala, and Saudi Arabia.
Product codes and lots: Part number: C-UDLMY-401J- CHILDRENS-HCT, Global part number: G44038 Lot: F2355271.

Product code FOZ

K081113Class IICook and Cook Spectrum Central Venous CathetersCook, Inc. / cleared 2008-07-30

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)