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Safety

Recall -- Firm Press Release

 

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.

 

Centurion Medical Products Initiates Voluntary Recall of Customized Convenience Kits (including select Central Venous Catheter, PICC Insertion, and VAD Trays) that contain American Regent’s Bacteriostatic Sodium Chloride Injection, USP, 0.9% 30 mL Multiple Dose Vials

 

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

FOR IMMEDIATE RELEASE - April 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

MaterialMaterial DescribtionBatch
CVI2615PICC INSERTION TRAY2010050750
301-00INSERTION TRAY2009092850
2010012950
2010030150
2010043050
2010061850
2010062950
2010082650
CVI2050PICC LINE TRAY2010071650
CVI2590INSERTION/PPE KIT2009102850
2009121750
2010030250
2010061550
2010072650
CVI2685PICC INSERTION TRAY2009102650
2010021950
2010040550
2010040850
CVI2690PICC INSERTION TRAY2010050750
2010080950
2010081150
2010090750
CVI2795 PICC INSERTION TRAY2009100950
2009111250
2010010650
2010011150
2010021150
2010022250
2010041250
2010091050
 CVI2880 PICC LINE KIT2009092550
2009111850
2009121150
2009122150
2010032550
2010040550
2010050450
2010052850
2010082650
 CVI2960PICC LINE TRAY2010010750
2010031150
2010032250
2010051350
2010062950
2010090150
CVI2970UNIVERSAL INSERTION / PROTECTION KIT2010011250
2010020150
2010051950
2010060450
2010071250
2010080450
CVI2980PICC INSERTION TRAY2010020850
2010030950
2010031650
2010041350
2010050450
CVI3015ADULT PICC INSERTION TRAY2009093050
2009113050
2009120850
2009123050
2010020350
2010030550
2010042050
2010050750
2010061050
2010072350
2010090750
CVI3030TEMPORARY PACEMAKER INSERTION TRAY2010022350
2010043050
CVI3070CENTRAL LINE PROCEDURE TRAY2009092450
2009100150
2010020950
CVI3105PICC INSERTION KIT2010011350
2010012050
2010020850
CVI3145CENTRAL LINE INSERTION BUNDLE2009102950
2010010650
2010011350
2010021150
2010022450
2010051850
2010061550
2010072050
2010081850
2010091750
CVI3155PICC INSERTION TRAY2009101250
2009120250
2009123150
2010022350
2010031950
2010041650
2010060750
2010072150
2010081350
2010090750
CVI3270PICC INSERTION TRAY2009101250
2009110250
2009112350
2009122850
2010031950
2010041550
2010051150
2010070950
2010082050
CVI3325PICC LINE INSERTION KIT2009102650
CVI3435INTRODUCER BUNDLE2010060450
2010081250
2010090750
 CVI680BCENTRAL CATHETER INSERTION TRAY2009091850
2009111150
2009120950
2010011950
2010020250
2010031150
2010052750
2010072350
2010081250
2010090250
 CVI980PICC INSERTION TRAY2009092550
2009103050
2009112350
2009121850
2010020550
DT10010PICC/MIDLINE INSERTION TRAY2009093050
2009101550
2009112450
DT10510INSERTION/PROTECTION KIT2009092550
2009102950
2009111350
2009121550
2009121650
2010012250
2010031850
2010042250
2010051350
2010072850
2010082550
DT10595CENTRAL LINE INSERTION TRAY2010030550
2010080350
2010090150
DT10605INSERTION/PROTECTION KIT2009091750
2009101550
2009110650
2009111950
2009120450
2009122850
DT10605INSERTION/PROTECTION KIT2010012850
2010041650
2010052750
2010070750
2010080250
DT11315CENTRAL LINE ACCESSORY PACK2010010550
2010020150
2010030850
2010032450
2010050450
2010061450
2010072250
 DT11375 PICC PROCEDURE TRAY2009101950
2009121850
2010010850
2010021250
2010030350
2010041650
2010063050
2010072150
2010091050
DT11520 CVC ACCESSORY KIT2009120850
2009122950
2010031750
2010040850
2010052550
2010062250
2010081250
2010092150
DT11980VAD TRAY2009092450
2009102950
2009120950
2010012750
2010021150
2010042250
2010052450
2010062450
2010072750
2010081950
DT12050PORT ACCESS TRAY2009100950
2009103050
2009120750
2009122850
2010060350
2010062250
2010070950
2010081850
2010082450
2010082650
DT12210CENTRAL LINE PROCEDURE KIT2010062150
DT12400PORT ACCESS TRAY2009100950
2009112550
2010010550
2010020950
2010030450
2010040850
2010042350
2010052150
2010081150
2010091750
DT12405NERVE BLOCK TRAY2009092550
DT12910PORT ACCESS TRAY W/ SECUREVIEW2009091750
2009101550
2009102950
2010020450
2010030150
2010041650
2010052050
2010062850
2010072850
DT13225TRIPLE LUMEN INSERTION/PROTECTION ( P/S)2009120350
2009123150
2010031750
2010050550
2010052650
2010072150
2010090850
 DT13770 DRESSING CHANGE TRAY2009100750
2009102150
DT14425PICC INSERTION BUNDLE2010020950
2010052550
2010062950
2010071450
2010081350
2010092250
DT14430PICC PROCEDURE TRAY2009101450
DT14805PICC PROCEDURE TRAY2010040850
DT14875OUT-PATIENT PORT ACCESS DRESSING TRAY2010030850
2010042850
2010051450
2010060350
2010061650
2010071550
2010080550
DT14880IN-PATIENT PORT ACCESS DRESSING TRAY P/S2010031250
2010032250
2010060150
2010061050
2010080450
2010090950
 DT5035PORT ACCESS TRAY2009122950
2010081950
DT5245PORT ACCESS TRAY2009113050
2009122950
2010012950
2010042050
2010043050
2010060950
2010082650
DT6110PORT ACCESS TRAY WITH HUBER NEEDLE
DT6475BPORT ACCESS TRAY2009091550
2009111850
2010012050
2010022450
2010041550
2010051850
2010062950
2010080450
2010090850
DT6755VAD DRESSING TRAY2009101450
2009120250
2009122950
2010081850
DT6765PORT CATH TRAY2009100550
2009110350
2009120450
2009122850
2010012950
2010032350
2010050450
2010060850
2010091450
DT6945BPORT CATH TRAY2009092250
2009100850
2009111150
2009122250
2009123150
2010020550
2010041550
2010052750
2010072750
2010082650
DT7035VAD INSERTION TRAY2009110650
2009111650
DT7135PORT ACCESS TRAY2009110650
2010012550
2010022650
2010032250
2010040750
2010061850
DT7150PORT ACCESS TRAY2009101950
2010011150
2010041650
2010060150
2010060350
2010081950
2010082650
DT7550PORT ACCESS TRAY2009100750
2009101950
2010010550
2010021950
2010031250
2010041250
2010052150
2010080350
2010090750
 DT7890PORT ACCESS TRAY2009101950
2010010650
DT8415PORT ACCESS TRAY W/SORBAVIEW SHIELD2009092450
2009101350
2009110650
2009121550
2010020950
2010021850
2010031950
2010041550
2010052150
2010080350
DT8915VAD KIT2010090750
2010111550
2010112950
 DT9155 PORT ACCESS TRAY W/SORBAVIEW&CHLORAPREP2009100550
2009111650
2009121550
2010021950
2010040550
2010060950
2010062850
DT9155PORT ACCESS TRAY2009092450
2010021050
2010042250
2010051950
2010060950
DT9345EDRESSING CHANGE TRAY2009092850
2010012050
2010022650
2010032950
2010060250
2010072150
2010081850
DT9460PICC INSERTION2009102350
2009110350
2009111950
2009112050
2010020950
DT9750VAD ACCESS TRAY2009120250
2010051850
ECVC1020TRIPLE LUMEN BUNDLE KIT W/CATHETER P/S2010042650
ECVC1040CENTRAL LINE INSERTION BUNDLE2010032350
2010042750
2010062150
2010062550
2010090350
ECVC1140TRIPLE LUMEN INSERTION KIT2010052850
ECVC1285TRIPLE LUMEN CENTRAL LINE BUNDLE2010091650
ECVC215CVC MULTI-LUMEN INSERTION BUNDLE2009110550
ECVC270CENTRAL LINE INSERTION BUNDLE2009102350
2009121750
2010020350
2010021050
2010030150
2010041250
ECVC280CVC MULTI LUMEN INSERTION BUNDLE2010020450
2010031650
2010042050
2010081650
2010082550
2010091750
ECVC355CVC INSERTION BUNDLE2009100650
2009110250
2009121150
2010072850
ECVC405P-CVC MULTI-LUMEN INSERTION BUNDLE2009102050
2009110550
2010040950
2010041450
2010071250
2010072850
2010082550
ECVC465CVC TRIPLE LUMEN KIT2009100750
2009102350
2010012250
2010012550
2010063050
2010092950
ECVC470CVC BUNDLE2010031250
2010062850
 ECVC540 CVC TRIPLE LUMEN BUNDLE KIT2009102050
2010011250
ECVC575MULTI-LUMEN CVC TRAY2010011350
2010073050
2010081250
ECVC590CENTRAL VENOUS CATH BUNDLE TRAY2009112050
2010020950
2010032250
ECVC895CENTRAL LINE INSERTION BUNDLE2010020450
2010061550
ECVC950CVC TRIPLE LUMEN BUNDLE, 7FR/16CM2010060750
2010092950
ECVC955CVC TRIPLE LUMEN BUNDLE, 7FR/20CM2010052850
2010072850
2010092950
HT1995A;V.A.D.TRAY2009102950
2009121550
2010012250
2010021550
2010033050
2010042850
2010060850
2010061050
2010082650
2010090850
 HT2415VAD ACCESS KIT2010090150
2009092350
2009101950
2009111850
2010012950
2010041350
2010060450
2010061650
2010072250
2010090750
HT2430AV.A.D.TRAY2009100850
2009101950
2009102850
2009110350
2009112450
2010060850
2010072150
2010090250
HT2440AVAD ACCESS TRAY2009100950
2009102250
2009112450
2009121650
2010030250
2010032350
2010041650
2010052150
2010062450
2010082650
2010091750
 HT2480V.A.D. TRAY2009111850
 ULT2170 ULTIMATE LINE TRAY2010020350
2010021650
2010030150
2010071350
ULT2170AULTIMATE LINE TRAY2009100850
2009102650
2009112550
2009121650
2010012650
2010020450
2010020850
2010031950
2010051350
2010082750
 ULT2175ULTIMATE LINE TRAY2010021550
2010042850
2010052650
2010070850
2010081950

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