Panels › General Hospital › Product code LRS · Class 2

I.V. Start Kit

Regulation 880.5200

0510(k)s in 12 months (30 all time)

15recalls in 12 months (166 all time)

11recalls that name a 510(k)

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Top companies in LRS

Company	510(k)s	Recalls
Centurion Medical Products	0	96
Covidien LLC	0	14
MEDLINE INDUSTRIES, LP - Northfield	0	13
Medline Industries, LP	0	9
Tri-State Hospital Supply Corporation	0	7
ARROW INTERNATIONAL, LLC	0	4
Cardinal Health 200, LLC	0	4
Stradis Healthcare	0	4
Busse Hospital Disposables, Inc.	1	2
Windstone Medical Packaging, Inc.	0	3

Date	Firm and product	Code	Linked 510(k)
Oct 3, 2017	Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc. Vygon IV Start Convenience Kits; Product Codes AMS-623T and AMS-626TGSLF. Kit used when administering IV during emergency. Terminated	LRS	K882503
Jul 29, 2016	B. Braun Medical, Inc. Sterile IV Start Kits 50 units/trays per case Convenience kit for IV start procedures Terminated	LRS	None listed
May 31, 2016	Covidien LLC Vistec X-Ray Detectable Sponges, 26 Ply, 8" x 4" (20.3 cm x 10.2 cm) Item Number: 7321 Terminated	LRS	None listed
May 31, 2016	Covidien LLC Vistec X-Ray Detectable Sponges, 16 Ply, 8" x 4" (20.3 cm x 10.2 cm) Item Number: 7319 Terminated	LRS	None listed
May 31, 2016	Covidien LLC Curity" X-Ray Detectable Laparotomy Sponges, Soft Pouch Pack, 8" x 36" (20.3 cm x 91.4 cm) Item Number: 6556 Terminated	LRS	None listed
May 31, 2016	Covidien LLC Curity X-Ray Detectable Laparotomy Sponges, Soft Pouch Pack, 4" x 18" (10.2 cm x 45.7 cm) Item Number: 6545 Terminated	LRS	None listed
May 31, 2016	Covidien LLC Curity X-Ray Detectable Laparotomy Sponges, Soft Pouch Pack, 12" x 12" (30.5 cm x 30.5 cm) Item Number:6534 Terminated	LRS	None listed
May 31, 2016	Covidien LLC Curity X-Ray Detectable Laparotomy Sponges, Soft Pouch Pack, 18" x 18" (45.7 cm x 45.7 cm) Item Number:6522 Terminated	LRS	None listed
May 31, 2016	Covidien LLC Curity X-Ray Detectable Laparotomy Sponges, Tray Pack, 8" x 36" (20.3 cm x 91.4 cm Item Number: 6056 Terminated	LRS	None listed
May 31, 2016	Covidien LLC Curity X-Ray Detectable Laparotomy Sponges, Tray Pack, 18" x 18" (45.7 cm x 45.7 cm) Item Number: 6022 Terminated	LRS	None listed
May 31, 2016	Covidien LLC Kerlix" X-Ray Detectable Laparotomy Sponges, Tray Pack, 8" x 32" (20.3 cm x 81.3 cm) Item Number: 4037 Terminated	LRS	None listed
May 31, 2016	Covidien LLC Kerlix X-Ray Detectable Laparotomy Sponges, Tray Pack, 17" x 26" (43.2 cm x 66 cm) Item Number: 4031 Terminated	LRS	None listed
May 31, 2016	Covidien LLC Curity All Purpose Sponges, Non-woven, 4 Ply, Soft Pouch, 4" x 4" (10.2 cm x 10.2 cm) Item Number: 8047 Terminated	LRS	None listed
May 31, 2016	Covidien LLC Kerlix" X-Ray Detectable Laparotomy Sponges, Tray Pack, 16" x 17" (40.6 cm x 43.2 cm) Item Number: 4034 Terminated	LRS	None listed
May 31, 2016	Covidien LLC Curity Gauze Sponges, 16 ply 4" x 4" (10.2 cm x 10.2 cm), Sterile 10's in Soft Pouch; Item Number: 397310; Open mesh fabric intended to be used to inside the body or a surgical incision to control bl Terminated	LRS	None listed
Mar 21, 2016	Windstone Medical Packaging, Inc. General Surgery Pack, part number 006880-3. This is a custom convenience surgical instrument disposable kit. There are multiple component in this kit and the recalled item subject to recall is Med Terminated	LRS	None listed
Mar 21, 2016	Windstone Medical Packaging, Inc. Laparotomy Pack Latex Free, part number 007725-7. This is a custom convenience surgical instrument disposable kit. There are multiple component in this kit and the recalled item subject to recall Terminated	LRS	None listed
Mar 21, 2016	Windstone Medical Packaging, Inc. Laparotomy Pack, Part numbers 006268-8 and 007725-8. This is a custom convenience surgical instrument disposable kit. There are multiple component in this kit and the recalled item subject to reca Terminated	LRS	None listed
May 11, 2013	Covidien LLC Curity I.V. Start Kit, Product ID: 80530 and Curity I.V. Start Kit Product ID: 8508. IV Start Kit. Terminated	LRS	K842898
Aug 22, 2011	Churchill Medical Systems, Inc. Churchill Medical Latex-Free IV Start Kit Product Code: AMS-623ATLF The kit includes a tourniquet, alcohol prep pads, a PVP ampule swab, 1 3M" Transpore tape roll, 2 gauze sponges, a 3M" Tegaderm" dr Terminated	LRS	None listed
May 27, 2011	Centurion Medical Products Corporation Material ECVC280, CVC MULTI LUMEN INSERTIN BUNDLE, CENTURION CVC MULTI LUMEN INSERTIN BUNDLE, REORDER ECVC280, STERILE, LATEX FREE, CENTURION MEDICAL PRODUCTS CORP. WILLIAMSTON MI 48895, USA 800.248 Terminated	LRS	None listed
May 27, 2011	Centurion Medical Products Corporation Material ULT2175, ULTIMATE LINE TRAY, CENTURION ULTIMATE LINE TRAY, REORDER ULT2175, STERILE, LATEX FREE, CENTURION MEDICAL PRODUCTS CORP. WILLIAMSTON MI 48895, USA 800.248.4058 www.centurionmp.com F Terminated	LRS	None listed
May 27, 2011	Centurion Medical Products Corporation Material ULT2170A, ULTIMATE LINE TRAY, CENTURION ULTIMATE LINE TRAY, REORDER ULT2170A, STERILE, CENTURION MEDICAL PRODUCTS CORP. WILLIAMSTON MI 48895, USA 800.248.4058 www.centurionmp.com FACILITATE Terminated	LRS	None listed
May 27, 2011	Centurion Medical Products Corporation Material ULT2170, ULTIMATE LINE TRAY, CENTURION ULTIMATE LINE TRAY, REORDER ULT2170, STERILE, CENTURION MEDICAL PRODUCTS CORP. WILLIAMSTON MI 48895, USA 800.248.4058 www.centurionmp.com FACILITATE Terminated	LRS	None listed
May 27, 2011	Centurion Medical Products Corporation Material ECVC955, CVC TRIPLE LUMEN BUNDLE, 7FR/20CM, CENTURION CVC TRIPLE LUMEN BUNDLE, REORDER ECVC955, LATEX FREE, STERILE, CENTURION MEDICAL PRODUCTS CORP. HOWELL MI 48843 USA 800.248.4058 www.cen Terminated	LRS	None listed
May 27, 2011	Centurion Medical Products Corporation Material ECVC950, CVC TRIPLE LUMEN BUNDLE, 7FR/16CM, CENTURION CVC TRIPLE LUMEN BUNDLE, 7FR/16CM, REORDER ECVC950, LATEX FREE, STERILE, CENTURION MEDICAL PRODUCTS CORP. HOWELL MI 48843 USA 800.248.405 Terminated	LRS	None listed
May 27, 2011	Centurion Medical Products Corporation Material ECVC590, CENTRAL VENOUS CATH BUNDLE TRAY, CENTURION CENTRAL VENOUS CATHETERIZATION BUNDLE TRAY, REORDER ECVC590, STERILE, LATEX FREE, CENTURION MEDICAL PRODUCTS CORP. WILLIAMSTON MI 48895, U Terminated	LRS	None listed
May 27, 2011	Centurion Medical Products Corporation Material ECVC895, CENTRAL LINE INSERTION BUNDLE, CENTURION CENTRAL LINE INSERTION BUNDLE, REORDER ECVC895, STERILE, LATEX FREE, CENTURION MEDICAL PRODUCTS CORP. WILLIAMSTON MI 48895, USA 800.248.405 Terminated	LRS	None listed
May 27, 2011	Centurion Medical Products Corporation Material ECVC575, MULTI-LUMEN CVC TRAY, CENTURION HURON MED CTR MULTI-LUMEN CVC TRAY, REORDER ECVC575, STERILE, LATEX FREE, CENTURION MEDICAL PRODUCTS CORP. WILLIAMSTON MI 48895, USA 800.248.4058 ww Terminated	LRS	None listed
May 27, 2011	Centurion Medical Products Corporation Material ECVC540, CVC TRIPLE LUMEN BUNDLE KIT, CENTURION CVC TRIPLE LUMEN BUNDLE KIT, REORDER ECVC540, STERILE, LATEX FREE, CENTURION MEDICAL PRODUCTS CORP. WILLIAMSTON MI 48895, USA 800.248.4058 ww Terminated	LRS	None listed
May 27, 2011	Centurion Medical Products Corporation Material ECVC470, CVC BUNDLE, CENTURION ST. JOHN CVC BUNDLE, REORDER ECVC470, STERILE, CENTURION MEDICAL PRODUCTS CORP. WILLIAMSTON MI 48895, USA 800.248.4058 www.centurionmp.com FACILITATES LINE Terminated	LRS	None listed
May 27, 2011	Centurion Medical Products Corporation Material ECVC465, CVC TRIPLE LUMEN KIT, CENTURION CVC TRIPLE LUMEN KIT, REORDER ECVC465, STERILE, LATEX FREE, CENTURION MEDICAL PRODUCTS CORP. WILLIAMSTON MI 48895, USA 800.248.4058 www.centurionmp. Terminated	LRS	None listed
May 27, 2011	Centurion Medical Products Corporation Material ECVC405, CVC MULTI-LUMEN INSERTION BUNDLE, CENTURION CVC MULTI-LUMEN INSERTION BUNDLE, REORDER ECVC405, STERILE, LATEX FREE, CENTURION MEDICAL PRODUCTS CORP. WILLIAMSTON MI 48895, USA 800.2 Terminated	LRS	None listed
May 27, 2011	Centurion Medical Products Corporation Material ECVC355, CVC INSERTION BUNDLE, CENTURION CHARLES COLE CVC INSERTION BUNDLE, REORDER ECVC355, STERILE, LATEX FREE, CENTURION MEDICAL PRODUCTS CORP. WILLIAMSTON MI 48895, USA 800.248.4058 www Terminated	LRS	None listed
May 27, 2011	Centurion Medical Products Corporation Material ECVC270, CENTRAL LINE INSERTION BUNDLE, CENTURION CENTRAL LINE INSERTION BUNDLE, REORDER ECVC270, STERILE, LATEX FREE, CENTURION MEDICAL PRODUCTS CORP. WILLIAMSTON MI 48895, USA 800.248.405 Terminated	LRS	None listed
May 27, 2011	Centurion Medical Products Corporation Material ECVC215, CVC MULTI-LUMEN INSERTION BUNDLE, CENTURION CVC MULTI-LUMEN INSERTION BUNDLE, REORDER ECVC215, STERILE, LATEX FREE, CENTURION MEDICAL PRODUCTS CORP. WILLIAMSTON MI 48895, USA 800.2 Terminated	LRS	None listed
May 27, 2011	Centurion Medical Products Corporation Material ECVC1285, TRIPLE LUMEN CENTRAL LINE BUNDLE, CENTURION TRIPLE LUMEN CENTAL LINE BUNDLE, REORDER ECVC1285, STERILE, LATEX FREE, CENTURION MEDICAL PRODUCTS CORP. WILLIAMSTON MI 48895, USA 800. Terminated	LRS	None listed
May 27, 2011	Centurion Medical Products Corporation Material ECVC1140, TRIPLE LUMEN INSERTION KIT, CENTURION TRIPLE LUMEN INSERTION KIT, REORDER ECVC1140, STERILE, LATEX FREE, CENTURION MEDICAL PRODUCTS CORP. WILLIAMSTON MI 48895, USA 800.248.4058 ww Terminated	LRS	None listed
May 27, 2011	Centurion Medical Products Corporation Material ECVC1040, CENTRAL LINE INSERTION BUNDLE, CENTURION CENTRAL LINE INSERTION BUNDLE, REORDER ECVC1040, STERILE..., LATEX FREE, CENTURION MEDICAL PRODUCTS CORP. WILLIAMSTON MI 48895, USA 800.24 Terminated	LRS	None listed
May 27, 2011	Centurion Medical Products Corporation Material ECVC1020, TRIPLE LUMEN BUNDLE KIT W/CATHETER, CENTURION TRIPLE LUMEN BUNDLE KIT WITH CATHETER, REORDER ECVC1020, LATEX FREE, STERILE, CENTURION MEDICAL PRODUCTS CORP. HOWELL MI 48843 USA 800. Terminated	LRS	None listed
May 27, 2011	Centurion Medical Products Corporation Material DT9460, PICC INSERTION TRAY, CENTURION PICC INSERTION TRAY, REORDER DT9460, STERILE, LATEX FREE, CENTURION MEDICAL PRODUCTS CORP. WILLIAMSTON MI 48895, USA 800.248.4058 www.centurionmp.com Terminated	LRS	None listed
May 27, 2011	Centurion Medical Products Corporation Material DT8915, VAD KIT, CENTURION VAD KIT, REORDER DT8915, STERILE..., LATEX FREE, CENTURION MEDICAL PRODUCTS CORP. WILLIAMSTON MI 48895, USA 800.248.4058 www.centurionmp.com FACILITATES LINE IN Terminated	LRS	None listed
May 27, 2011	Centurion Medical Products Corporation Material DT14805, PICC PROCEDURE TRAY, CENTURION PICC PROCEDURE TRAY, REORDER DT14805, STERILE, LATEX FREE, CENTURION MEDICAL PRODUCTS CORP. WILLIAMSTON MI 48895, USA 800.248.4058 www.centurionmp.co Terminated	LRS	None listed
May 27, 2011	Centurion Medical Products Corporation Material DT14430, PICC PROCEDURE TRAY, CENTURION PICC PROCEDURE TRAY, REORDER DT14430, STERILE, LATEX FREE, CENTURION MEDICAL PRODUCTS CORP. WILLIAMSTON MI 48895, USA 800.248.4058 www.centurionmp.co Terminated	LRS	None listed
May 27, 2011	Centurion Medical Products Corporation Material DT14425, PICC INSERTION BUNDLE, CENTURION PICC INSERTION BUNDLE, REORDER DT14425, STERILE, LATEX FREE, CENTURION MEDICAL PRODUCTS CORP. WILLIAMSTON MI 48895, USA 800.248.4058 www.centurionm Terminated	LRS	None listed
May 27, 2011	Centurion Medical Products Corporation Material DT13225, TRIPLE LUMEN INSERTION/ PROTECTION ( P/S), CENTURION TRIPLE LUMEN INSERTION/ PROTECTION ( P/S), REORDER DT13225, STERILE, LATEX FREE, CENTURION MEDICAL PRODUCTS CORP. WILLIAMSTON MI Terminated	LRS	None listed
May 27, 2011	Centurion Medical Products Corporation Material DT12405, NERVE BLOCK TRAY, CENTURION NERVE BLOCK TRAY, REORDER DT12405, LATEX FREE, STERILE, CENTURION MEDICAL PRODUCTS CORP. HOWELL MI 48843 USA 800.248.4058 www.centurionmp.com FACILITATE Terminated	LRS	None listed
May 27, 2011	Centurion Medical Products Corporation Material DT12210, CENTRAL LINE PROCEDURE KIT, CENTURION CENTRAL LINE PROCEDURE KIT, REORDER DT12210, STERILE, CENTURION MEDICAL PRODUCTS CORP. WILLIAMSTON MI 48895, USA 800.248.4058 www.centurionmp. Terminated	LRS	None listed
May 27, 2011	Centurion Medical Products Corporation Material DT11375, PICC PROCEDURE TRAY, CENTURION PICC Procedure Tray, Reorder DT11375, STERILE, LATEX-FREE, CENTURION MEDICAL PRODUCTS CORP. WILLIAMSTON MI I 48895 USA 800.248.4058 www.centurionmp. Terminated	LRS	None listed
May 27, 2011	Centurion Medical Products Corporation Material DT11315, CENTRAL LINE ACCESSORY PACK, CENTURION CENTAL LINE ACCESSORY PACK, REORDER DT11315, STERILE, LATEX-FREE, CENTURION MEDICAL PRODUCTS CORP. WILLIAMSTON MI 48895 USA 800.248.4058 w Terminated	LRS	None listed

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