FDA Medical Device Recalls (openFDA)
Cook, Inc.: Spectrum Central Venous Tray Minocycline/Rifampin Impregnated Triple Lumen Polyurethane Catheter, 7.0 Fr/ 15 cm Power Injectable, C-UTLMY-701J-ABRM-HC-IHI-FST-A-RD, G49803, Sterile, Cook Medical, Cook Incorporated, Bloomington, IN.
- Recall number
- Z-1191-2011
- Recalling firm
- Cook, Inc.
- Product
- Spectrum Central Venous Tray Minocycline/Rifampin Impregnated Triple Lumen Polyurethane Catheter, 7.0 Fr/ 15 cm Power Injectable, C-UTLMY-701J-ABRM-HC-IHI-FST-A-RD, G49803, 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 trays
- Distribution
- Worldwide distribution: USA, Chile, Colombia, Panama, Barbados, Canada, Guatemala, and Saudi Arabia.
- Lot, serial or model codes
- Part number: C-UTLMY-701J-ABRM-HC-IHI-FST-A-RD, Global part number G49803. Lot numbers: 2240346; 2241834; 2245786; 2248322; 2249284; 2251999; 2253344; 2255176; 2255741; 2259342; 2268075; 2269800; 2276914; 2277908; 2281660; 2282559; 2285525; 2286943; 2291838; 2293485; 2294042; 2297529; 2299454; 2303178; 2306599; 2309430; 2311594; 2315346; 2316748; 2317453; 2318707; 2318718; 2318843; 2321268; 2321271; 2321282; 2321283; 2321299; 2325081; 2325083; 2325094; 2329811; 2331460; 2335177.
- 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