FDA Medical Device Recalls (openFDA)
Cook, Inc.: Spectrum Central Venous Catheter Tray, Minocycline/Rifampin Antibiotic Impregnated, Double Lumen Polyurethane, 4.0 Fr/8 cm, C-UDLMY-401J- ABRM-HC-FST, G43991, Sterile, Cook Medical, Cook Incorporated, Bloomington, IN.
- Recall number
- Z-1124-2011
- Recalling firm
- Cook, Inc.
- Product
- Spectrum Central Venous Catheter Tray, Minocycline/Rifampin Antibiotic Impregnated, Double Lumen Polyurethane, 4.0 Fr/8 cm, C-UDLMY-401J- ABRM-HC-FST, G43991, Sterile, Cook Medical, Cook Incorporated, Bloomington, IN.
- Status
- Terminated
- Initiated
- 2010-10-04
- Posted
- 2011-02-23
- Terminated
- 2011-06-21
- Reason
- 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
- 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
- 51,473 total kits/trays
- Distribution
- Worldwide distribution: USA, Chile, Colombia, Panama, Barbados, Canada, Guatemala, and Saudi Arabia.
- Lot, serial or model codes
- Part Number: C-UDLMY-401J-ABRM-HC-FST; Global Part Number G43991, lots 2239671, 2240332, 2241244, 2242374, 2242385, 2244239, 2246215, 2247660, 2251149, 2251993, 2253260, 2254294, 2255154, 2255167, 2256085, 2256086, 2256091, 2256094, 2256106, 2258322, 2263457, 2266466, 2268899, 2270663, 2275438, 2275487, 2278553, 2279206, 2282639, 2282640, 2282641, 2285514, 2285550, 2291774, 2294744, 2296185, 2302089, 2304442, 2307476, 2308272, 2309333, 2309424, 2313807, 2316752, 2318742, 2318831, 2321683, 2327490, 2330564, 2332346, 2337150 and 2279206X
- 510(k) numbers
- ["K081113"]
- PMA numbers
- not on file
- Product code
- FOZ
- Firm FEI
- 1820334
- Firm city
- Bloomington
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28