Centurion Medical Products Initiates Voluntary Recall of Customized Convenience Kits (including select Central Venous Catheter,

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Contact:
Centurion’s Recall Coordinator
800-248-4058, extension 1156

FOR IMMEDIATE RELEASE - Aril 1, 2011 -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

Recalled Kits

Material	Material Describtion	Batch
CVI2615	PICC INSERTION TRAY	2010050750
301-00	INSERTION TRAY	2009092850 2010012950 2010030150 2010043050 2010061850 2010062950 2010082650
CVI2050	PICC LINE TRAY	2010071650
CVI2590	INSERTION/PPE KIT	2009102850 2009121750 2010030250 2010061550 2010072650
CVI2685	PICC INSERTION TRAY	2009102650 2010021950 2010040550 2010040850
CVI2690	PICC INSERTION TRAY	2010050750 2010080950 2010081150 2010090750
CVI2795	PICC INSERTION TRAY	2009100950 2009111250 2010010650 2010011150 2010021150 2010022250 2010041250 2010091050
CVI2880	PICC LINE KIT	2009092550 2009111850 2009121150 2009122150 2010032550 2010040550 2010050450 2010052850 2010082650
CVI2960	PICC LINE TRAY	2010010750 2010031150 2010032250 2010051350 2010062950 2010090150
CVI2970	UNIVERSAL INSERTION / PROTECTION KIT	2010011250 2010020150 2010051950 2010060450 2010071250 2010080450
CVI2980	PICC INSERTION TRAY	2010020850 2010030950 2010031650 2010041350 2010050450
CVI3015	ADULT PICC INSERTION TRAY	2009093050 2009113050 2009120850 2009123050 2010020350 2010030550 2010042050 2010050750 2010061050 2010072350 2010090750
CVI3030	TEMPORARY PACEMAKER INSERTION TRAY	2010022350 2010043050
CVI3070	CENTRAL LINE PROCEDURE TRAY	2009092450 2009100150 2010020950
CVI3105	PICC INSERTION KIT	2010011350 2010012050 2010020850
CVI3145	CENTRAL LINE INSERTION BUNDLE	2009102950 2010010650 2010011350 2010021150 2010022450 2010051850 2010061550 2010072050 2010081850 2010091750
CVI3155	PICC INSERTION TRAY	2009101250 2009120250 2009123150 2010022350 2010031950 2010041650 2010060750 2010072150 2010081350 2010090750
CVI3270	PICC INSERTION TRAY	2009101250 2009110250 2009112350 2009122850 2010031950 2010041550 2010051150 2010070950 2010082050
CVI3325	PICC LINE INSERTION KIT	2009102650
CVI3435	INTRODUCER BUNDLE	2010060450 2010081250 2010090750
CVI680B	CENTRAL CATHETER INSERTION TRAY	2009091850 2009111150 2009120950 2010011950 2010020250 2010031150 2010052750 2010072350 2010081250 2010090250
CVI980	PICC INSERTION TRAY	2009092550 2009103050 2009112350 2009121850 2010020550
DT10010	PICC/MIDLINE INSERTION TRAY	2009093050 2009101550 2009112450
DT10510	INSERTION/PROTECTION KIT	2009092550 2009102950 2009111350 2009121550 2009121650 2010012250 2010031850 2010042250 2010051350 2010072850 2010082550
DT10595	CENTRAL LINE INSERTION TRAY	2010030550 2010080350 2010090150
DT10605	INSERTION/PROTECTION KIT	2009091750 2009101550 2009110650 2009111950 2009120450 2009122850
DT10605	INSERTION/PROTECTION KIT	2010012850 2010041650 2010052750 2010070750 2010080250
DT11315	CENTRAL LINE ACCESSORY PACK	2010010550 2010020150 2010030850 2010032450 2010050450 2010061450 2010072250
DT11375	PICC PROCEDURE TRAY	2009101950 2009121850 2010010850 2010021250 2010030350 2010041650 2010063050 2010072150 2010091050
DT11520	CVC ACCESSORY KIT	2009120850 2009122950 2010031750 2010040850 2010052550 2010062250 2010081250 2010092150
DT11980	VAD TRAY	2009092450 2009102950 2009120950 2010012750 2010021150 2010042250 2010052450 2010062450 2010072750 2010081950
DT12050	PORT ACCESS TRAY	2009100950 2009103050 2009120750 2009122850 2010060350 2010062250 2010070950 2010081850 2010082450 2010082650
DT12210	CENTRAL LINE PROCEDURE KIT	2010062150
DT12400	PORT ACCESS TRAY	2009100950 2009112550 2010010550 2010020950 2010030450 2010040850 2010042350 2010052150 2010081150 2010091750
DT12405	NERVE BLOCK TRAY	2009092550
DT12910	PORT ACCESS TRAY W/ SECUREVIEW	2009091750 2009101550 2009102950 2010020450 2010030150 2010041650 2010052050 2010062850 2010072850
DT13225	TRIPLE LUMEN INSERTION/PROTECTION ( P/S)	2009120350 2009123150 2010031750 2010050550 2010052650 2010072150 2010090850
DT13770	DRESSING CHANGE TRAY	2009100750 2009102150
DT14425	PICC INSERTION BUNDLE	2010020950 2010052550 2010062950 2010071450 2010081350 2010092250
DT14430	PICC PROCEDURE TRAY	2009101450
DT14805	PICC PROCEDURE TRAY	2010040850
DT14875	OUT-PATIENT PORT ACCESS DRESSING TRAY	2010030850 2010042850 2010051450 2010060350 2010061650 2010071550 2010080550
DT14880	IN-PATIENT PORT ACCESS DRESSING TRAY P/S	2010031250 2010032250 2010060150 2010061050 2010080450 2010090950
DT5035	PORT ACCESS TRAY	2009122950 2010081950
DT5245	PORT ACCESS TRAY	2009113050 2009122950 2010012950 2010042050 2010043050 2010060950 2010082650
DT6110	PORT ACCESS TRAY WITH HUBER NEEDLE
DT6475B	PORT ACCESS TRAY	2009091550 2009111850 2010012050 2010022450 2010041550 2010051850 2010062950 2010080450 2010090850
DT6755	VAD DRESSING TRAY	2009101450 2009120250 2009122950 2010081850
DT6765	PORT CATH TRAY	2009100550 2009110350 2009120450 2009122850 2010012950 2010032350 2010050450 2010060850 2010091450
DT6945B	PORT CATH TRAY	2009092250 2009100850 2009111150 2009122250 2009123150 2010020550 2010041550 2010052750 2010072750 2010082650
DT7035	VAD INSERTION TRAY	2009110650 2009111650
DT7135	PORT ACCESS TRAY	2009110650 2010012550 2010022650 2010032250 2010040750 2010061850
DT7150	PORT ACCESS TRAY	2009101950 2010011150 2010041650 2010060150 2010060350 2010081950 2010082650
DT7550	PORT ACCESS TRAY	2009100750 2009101950 2010010550 2010021950 2010031250 2010041250 2010052150 2010080350 2010090750
DT7890	PORT ACCESS TRAY	2009101950 2010010650
DT8415	PORT ACCESS TRAY W/SORBAVIEW SHIELD	2009092450 2009101350 2009110650 2009121550 2010020950 2010021850 2010031950 2010041550 2010052150 2010080350
DT8915	VAD KIT	2010090750 2010111550 2010112950
DT9155	PORT ACCESS TRAY W/SORBAVIEW&CHLORAPREP	2009100550 2009111650 2009121550 2010021950 2010040550 2010060950 2010062850
DT9155	PORT ACCESS TRAY	2009092450 2010021050 2010042250 2010051950 2010060950
DT9345E	DRESSING CHANGE TRAY	2009092850 2010012050 2010022650 2010032950 2010060250 2010072150 2010081850
DT9460	PICC INSERTION	2009102350 2009110350 2009111950 2009112050 2010020950
DT9750	VAD ACCESS TRAY	2009120250 2010051850
ECVC1020	TRIPLE LUMEN BUNDLE KIT W/CATHETER P/S	2010042650
ECVC1040	CENTRAL LINE INSERTION BUNDLE	2010032350 2010042750 2010062150 2010062550 2010090350
ECVC1140	TRIPLE LUMEN INSERTION KIT	2010052850
ECVC1285	TRIPLE LUMEN CENTRAL LINE BUNDLE	2010091650
ECVC215	CVC MULTI-LUMEN INSERTION BUNDLE	2009110550
ECVC270	CENTRAL LINE INSERTION BUNDLE	2009102350 2009121750 2010020350 2010021050 2010030150 2010041250
ECVC280	CVC MULTI LUMEN INSERTION BUNDLE	2010020450 2010031650 2010042050 2010081650 2010082550 2010091750
ECVC355	CVC INSERTION BUNDLE	2009100650 2009110250 2009121150 2010072850
ECVC405	P-CVC MULTI-LUMEN INSERTION BUNDLE	2009102050 2009110550 2010040950 2010041450 2010071250 2010072850 2010082550
ECVC465	CVC TRIPLE LUMEN KIT	2009100750 2009102350 2010012250 2010012550 2010063050 2010092950
ECVC470	CVC BUNDLE	2010031250 2010062850
ECVC540	CVC TRIPLE LUMEN BUNDLE KIT	2009102050 2010011250
ECVC575	MULTI-LUMEN CVC TRAY	2010011350 2010073050 2010081250
ECVC590	CENTRAL VENOUS CATH BUNDLE TRAY	2009112050 2010020950 2010032250
ECVC895	CENTRAL LINE INSERTION BUNDLE	2010020450 2010061550
ECVC950	CVC TRIPLE LUMEN BUNDLE, 7FR/16CM	2010060750 2010092950
ECVC955	CVC TRIPLE LUMEN BUNDLE, 7FR/20CM	2010052850 2010072850 2010092950
HT1995A	;V.A.D.TRAY	2009102950 2009121550 2010012250 2010021550 2010033050 2010042850 2010060850 2010061050 2010082650 2010090850
HT2415	VAD ACCESS KIT	2010090150 2009092350 2009101950 2009111850 2010012950 2010041350 2010060450 2010061650 2010072250 2010090750
HT2430A	V.A.D.TRAY	2009100850 2009101950 2009102850 2009110350 2009112450 2010060850 2010072150 2010090250
HT2440A	VAD ACCESS TRAY	2009100950 2009102250 2009112450 2009121650 2010030250 2010032350 2010041650 2010052150 2010062450 2010082650 2010091750
HT2480	V.A.D. TRAY	2009111850
ULT2170	ULTIMATE LINE TRAY	2010020350 2010021650 2010030150 2010071350
ULT2170A	ULTIMATE LINE TRAY	2009100850 2009102650 2009112550 2009121650 2010012650 2010020450 2010020850 2010031950 2010051350 2010082750
ULT2175	ULTIMATE LINE TRAY	2010021550 2010042850 2010052650 2010070850 2010081950

Recalled Product Photos Are Also Available on FDA's Flickr Photostream.