Churchill Medical Systems, Inc.

FDA Regulatory Profile

Summary

Total Recalls
16
510(k) Clearances
12
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1477-2015Class II4" Trifurcated set with Bionectors and check valves, Product Code: BN-3082CV and BN-3083CV AccessorJanuary 15, 2015
Z-1468-2015Class IIBifircated Extension Set, Product Code: BN-828 Accessory device used to administer medical fluidsJanuary 15, 2015
Z-1474-2015Class II7" Standard Bore High Pressure Ext Set, Product Code: CMS-809 Accessory device used to administer mJanuary 15, 2015
Z-1471-2015Class II4" Microbore T-Port Set, Product Code: BN-448 Accessory device used to administer medical fluidsJanuary 15, 2015
Z-1476-2015Class IIBifurcated set with check vales and Bionectors, Product Code: BN-2082CV Accessory device used to adJanuary 15, 2015
Z-1478-2015Class II6" Trifurcated set with Bionectors, Product Code: BN-944 Accessory device used to administer medicaJanuary 15, 2015
Z-1475-2015Class II7" Standard Bore High Pressure Ext Set, Product Code: CMS-809 Accessory device used to administer mJanuary 15, 2015
Z-1469-2015Class II4" Microbore Double Lumen Set with Bionector, Product Code: BN-208 Accessory device used to adminisJanuary 15, 2015
Z-1473-2015Class II7" High Pressure Set with Bionector, Product Code: CMS-808 and CMS-808-1 Accessory device used to aJanuary 15, 2015
Z-1472-2015Class II8" Standard Bore Ext Set, Product Code: BN-481 Accessory device used to administer medical fluidsJanuary 15, 2015
Z-1467-2015Class II6" Trifurcated Extension Set, Product Code: AMS-375-1 Accessory device used to administer medical fJanuary 15, 2015
Z-1470-2015Class II4" Microbore Trifurcated Ext set, Product Code: BN-308 Accessory device used to administer medical January 15, 2015
Z-0813-2014Class IIAMS-530 7 Microbore Trifurcated Extension sets Product Usage: Intravascular administration seJanuary 7, 2014
Z-2252-2013Class IICentral Dressing Change Kit; AMS-8464CP- 6. Vygon Central Dressing Change Kit contains: 1 Pair NitAugust 12, 2013
Z-2251-2013Class IIVygon 14 Microbore Extension Set with Bionector, CMS-814-1. The CMS-814-1 is a 14 inch extension setAugust 12, 2013
Z-0914-2013Class IILifeguard Infusion Set with Smartsite, 20Ga, 1, CLGY-2010 Huber type needle set used for the infuJanuary 21, 2013

Recent 510(k) Clearances

K-NumberDeviceDate
K041038CHURCHILL MEDICAL DUAL CHAMBER EMPTY CONTAINERDecember 21, 2004
K021395MODIFICATION TO 30 EXTENSION SETMay 13, 2002
K013949UNIVERSAL VIAL ACCESS SPIKE WITH NEEDLELESS CONNECTORMarch 27, 2002
K020544WING SAFE INFUSION SET 20 GA, SHS2000 SERIES; WING SAFE INFUSION SET 19 GA, SHS1900 SERIES; WING SAFMarch 12, 2002
K013950VENTED VIAL ACCESS DEVICEJanuary 10, 2002
K012157CHURCHILL MEDICAL SYSTEMS STOPCOCKSeptember 11, 2001
K011888PRESSURE ACTIVATED CHECK VALVESeptember 10, 2001
K011336PRIMARY SOLUTION SET WITH UNIVERSAL SPIKE, INJECTION SITE AND MALE LUER LOCKJune 12, 2001
K896333CMS IV FILTERSJanuary 11, 1990
K894954.22 & 1.2 MICRON IV FILTERSNovember 13, 1989
K884370CMS IV EXTENSION SETSNovember 7, 1988
K88250330 IV EXTENSION SET W/TWO MALE LUER LOCKSAugust 25, 1988