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Terminated

Material CVI3015, ADULT PICC INSERTION TRAY, MANUFACTURED FOR LEE MEDICAL INC, 2550 Meridian Blvd. " Suite 200 " Franklin, TN 37067, REORDER CVI3015, STERILE FACILITATES PICC LINE PLACEMENT

FDA Recall Z-2307-2011 · Posted 2011-05-27

Recall StatusTerminated
Product CodeLRS
Date Initiated2011-03-31
Date Terminated2011-09-13
Product Quantity3940

Reason for Recall

This voluntary sub-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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