Recall Z-2223-2011 ยท LRS I.V. Start Kit
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
| Date | May 19, 2011 (initiated Apr 5, 2011) |
| Status | Terminated |
| 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 510-3 |
| Quantity | 1990 |
| Distribution | Worldwide Distribution -- USA, including states of MO, WA, PA, CA, OH, UT, TX and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.