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Centurion Medical Products Initiates Voluntary Recall of Customized Convenience Kits (including select Central Venous Catheter, PICC Insertion, and VAD Trays) that contain Ame...

Fri, 04/01/2011 - 4:20pm

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 - 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

##

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