FDA Medical Device Recalls (openFDA)
Cook, Inc.: 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.
- Recall number
- Z-0637-2007
- Recalling firm
- Cook, Inc.
- 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.
- Status
- Terminated
- Initiated
- 2007-01-02
- Posted
- 2007-03-16
- Terminated
- 2007-12-05
- Reason
- These catheters do not include the proximal sidehole as required by the specification.
- Root cause
- Other
- Action
- Consignees were notified by phone on 1/2/07 and instructed to return the product.
- Quantity
- 100
- Distribution
- Nationwide, including the states of Florida, Louisiana, Maine, Massachusetts, Minnesota, Missouri, New Jersey and North Carolina.
- Lot, serial or model codes
- Lots 1794998 and 1793611.
- 510(k) numbers
- ["K950118"]
- 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