FDA Medical Device Recalls (openFDA)
Neo Medical, Inc.: V-CATH Insertion Kits, Sterile; Product Code Number: 301-00; Manufactured by Centurion Medical Products for Neo Medical; 42514 Albrae Street, Fremont, CA 94538
- Recall number
- Z-2223-2011
- Recalling firm
- Neo Medical, Inc.
- Product
- V-CATH Insertion Kits, Sterile; Product Code Number: 301-00; Manufactured by Centurion Medical Products for Neo Medical; 42514 Albrae Street, Fremont, CA 94538
- Status
- Terminated
- Initiated
- 2011-04-05
- Posted
- 2011-05-19
- Terminated
- 2011-11-22
- Reason
- Firm received recall notice from their contract manufacturer due to visible particulates in Bacteriostatic Sodium Chloride Injection, USP 0.9%, 30 mL vials that are included in insertion kits.
- Root cause
- Material/Component Contamination
- Action
- Neo Medical forwarded Urgent Recall Notices to Dealers and customers on April 5, 2011 via fax. Neo Medical Customer Care also contacted customers by phone on April 7, 2011, followed by Urgent Product Recall Notification letters were sent on April 11, 2011 along with a copy of the Recall Notification from Centurion. The letter requested that customers with affected lots immediately discontinue distribution and contact the end users instructing them to stop dispensing the product. Customers were to complete the accountability information even if inventory had been depleted and fax it to 510-353-9025. In order to return the affected product, customers should contact the Complaint Coordinator at 925-719-2197 or pjduvall@neomedicalinc.com. Replacement or credit would be issued for all product returned.
- Quantity
- 1990
- Distribution
- Worldwide Distribution -- USA, including states of MO, WA, PA, CA, OH, UT, TX and Canada.
- Lot, serial or model codes
- Lot # Expiration Date 2009092850 5/31/2011 2010012950 5/31/2011 2010030150 8/31/2011 2010043050 8/31 2011 2010061850 12/31/2011 2010062950 12/31/2011 2010082650 12/31/2011
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LRS
- Firm FEI
- 2925153
- Firm city
- Fremont
- Firm state
- CA
- 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