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Centurion Medical Products Initiates Voluntary Recall of Customized Convenience Kits


4/4/2011 6:59:33 AM

WILLIAMSTON, MI--(Marketwire - 04/01/11) - Centurion Medical Products Corporation, of Williamston, Michigan, has initiated a recall of certain customized convenience kits that contain Bacteriostatic Sodium Chloride Injection, USP, 0.9% 30 mL Multiple Dose Vials manufactured by Luitpold Pharmaceuticals, Inc., and distributed by American Regent, Inc. This action is in response to American Regent's recall of three lots of vials because some may contain visible particulates.

These American Regent products were included in customized convenience kits manufactured by Centurion Medical Products for a total of one hundred and six (106) health care facilities in the United States only.

Centurion is voluntarily recalling affected products after learning of the American Regent, Inc. recall, and has ceased including these products in Centurion kits. FDA has been apprised of this action. The other components included in the kits are not affected by the recalled American Regent product.

This recall includes the code numbers listed in Attachment 1. These kits are customized for specific health care facilities. Centurion is notifying these customers and distributors by certified letter on March 31, 2011.

Bacteriostatic Sodium Chloride Injection, USP, 0.9% is used for preparing and diluting sterile solutions. To date, Centurion has not received any reports of adverse reactions from the use of this product.

Customers that have any of the affected products should not use them. Continued use of the affected lots of Bacteriostatic Sodium Chloride Injection products from American Regent, Inc. may result in potential adverse events such as disruption of blood flow within small blood vessels in the lung, localized inflammation (swelling and redness due to accumulation of inflammatory cells), and granuloma formation.

Customers with questions should contact Centurion's Recall Coordinator at 800-248-4058, extension 1156 (Monday through Friday, 7:00 am through 3:30 pm ET). To return product and receive credit or replacement product, customers are directed to contact Centurion's Recall Coordinator, as specified in the notices that have been distributed.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

* Online:www.fda.gov/medwatch/report.htm * Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at: www.fda.gov/MedWatch/getforms.htm. Mail to address on the pre-addressed form. * Fax: 1-800-FDA-0178

Matthew Price 517-546-5400 Centurion Medical Products Corporation 100 Centurion Way Williamston, MI 48895

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