Peripherally Inserted Central Venous Catheter Tray Silicone, CPICSY401HOPKINS0911 00, G13169, 4.0 Fr/60cm, Sterile, Cook

FDA device recall Z-1096-2011 · posted 2011-02-23 · Terminated

Recall details

Recalling firm

Cook, Inc.

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

Action taken

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.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

LJT

Quantity affected

51,473 total kits/trays

Distribution

Worldwide distribution: USA, Chile, Colombia, Panama, Barbados, Canada, Guatemala, and Saudi Arabia.

Date initiated

2010-10-04

Date posted

2011-02-23

Date terminated

2011-06-21

Location

Bloomington, IN