FDA Medical Device Recalls (openFDA)
Cook Vascular Inc.: Vital Port Vascular Access System Polysulfone Petite with detached 1.0mm catheter
- Recall number
- Z-2191-2008
- Recalling firm
- Cook Vascular Inc.
- Product
- Vital Port Vascular Access System Polysulfone Petite with detached 1.0mm catheter
- Status
- Terminated
- Initiated
- 2008-04-24
- Posted
- 2008-09-17
- Terminated
- 2008-09-18
- Reason
- mislabeled - wrong size catheter was packaged in the box
- Root cause
- Packaging process control
- Action
- The recalling firm issued an Urgent Product Recall letter dated 4/30/08 to inform their customers of the problem and the need to return the product. The letter also instructed the customers to notify sub accounts. Contact Cook Vascular at 1-724-845-8621 for assistance.
- Quantity
- 20 units
- Distribution
- The products were shipped to distributors in Japan and Brazil.
- Lot, serial or model codes
- Catalog number IP-S6118. Lot number N73153
- 510(k) numbers
- ["K924748"]
- PMA numbers
- not on file
- Product code
- LJT
- Firm FEI
- 2522007
- Firm city
- Vandergrift
- Firm state
- PA
- 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