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
FDA Recall Z-2297-2011 · Posted 2011-05-27
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Recalling FirmCenturion Medical Products Corporation
Recall StatusTerminated
Product CodeLRS
Date Initiated2011-03-31
Date Terminated2011-09-13
Product Quantity2180
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.
Firm 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.
Root Cause
Material/Component Contamination
Distribution Pattern
Nationwide Distribution
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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