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
Recall
- Recall Number
- Z-2297-2011
- Event Number
- 58346
- Firm
- Centurion Medical Products Corporation
- FEI Number
- 3008403546
- Product Code
- LRS
- Status
- Terminated
- Root Cause
- Material/Component Contamination
- Initiated
- March 31, 2011
- Posted
- May 27, 2011
- Terminated
- September 13, 2011
- Address
- 100 Centurion Way, Williamston, MI, 48895-9086
Description
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
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.
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.
Nationwide Distribution
2180