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

Posted Apr 01 2011 7:37pm
FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

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.

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.

    
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