Z-2297-2011

Material 301-00, INSERTION TRAY , NeoMedical Incorporated, V-CATH INSERTION TRAY, REF 30I -00, STERILE UNLESS...

Name: Z-2297-2011 Material 301-00, INSERTION TRAY , NeoMedical Incorporated, V-CATH INSERTION TRAY, REF 30I -00, STERILE UNLESS...
Creator: Centurion Medical Products Corporation
Published: 2011-03-31
License: https://open.fda.gov/license/

Centurion Medical Products, LP / initiated 2011-03-31 / Terminated / root cause: manufacturing process

FDA source

Centurion Medical Products Corporation began a recall of Material 301-00, INSERTION TRAY , NeoMedical Incorporated, V-CATH INSERTION TRAY, REF 30I -00, STERILE UNLESS PACKAGE IS OPENED OR DAMAGED, IHI COMPLIANT... on 2011-03-31. The reason FDA records is "This voluntary recall was initiated because the vials of Bacteriostatic Sodium Chloride Injection, USP, 0.9% utilized to make the products may contain visible particulates". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2297-2011
Status: Terminated
Initiated: 2011-03-31
Posted: 2011-05-27
Terminated: 2011-09-13
Recalling firm: Centurion Medical Products, LP
Product: Material 301-00, INSERTION TRAY , NeoMedical Incorporated, V-CATH INSERTION TRAY, REF 30I -00, STERILE UNLESS PACKAGE IS OPENED OR DAMAGED, IHI COMPLIANT, Manufactured by Centurion Medical Products Corp. for: NeoMedical, 42514 Albrae Street, Fremont, CA 94538 (888) 450-3334 " FAX (510) 353-9025 FACILITATES LINE PLACEMENT
Product code: LRS I.V. Start Kit
Reason for recall: This voluntary recall was initiated because the vials of Bacteriostatic Sodium Chloride Injection, USP, 0.9% utilized to make the products may contain visible particulates.
Root cause tag: manufacturing process
FDA root cause: Material/Component Contamination
Action: Centurion Medical Products Corporation issued press on April 1, 2011, and sent an Urgent Voluntary Recall letter dated March 15, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to discontinue use of the kits immediately and instructions were provided for the return of the kits. Customers were also asked to complete a form to fax or email back to the firm regarding the number of kits the firm has in their possession. Customers were instructed to provide recall notification to other firm's who received the recalled kits from their direct account. For any questions regarding this recall call 631-924-4000, ext 142.
Quantity in commerce: 2180
Distribution: Nationwide Distribution
Product codes and lots: BATCHES 2009092850, 2010012950, 2010030150, 20043050, 2010061850, 2010062950 AND 2010082650.

Product code LRS

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)