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Churchill Medical Systems, Inc.

36 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
6" Trifurcated Extension Set, Product Code: AMS-375-1 Accessory device used to administer recall (Z-1467-2015)Churchill Medical Systems, Inc.2015-04-21
Bifircated Extension Set, Product Code: BN-828 Accessory device used to administer medical recall (Z-1468-2015)Churchill Medical Systems, Inc.2015-04-21
4" Microbore Double Lumen Set with Bionector, Product Code: BN-208 Accessory device used t recall (Z-1469-2015)Churchill Medical Systems, Inc.2015-04-21
4" Microbore Trifurcated Ext set, Product Code: BN-308 Accessory device used to administer recall (Z-1470-2015)Churchill Medical Systems, Inc.2015-04-21
4" Microbore T-Port Set, Product Code: BN-448 Accessory device used to administer medical recall (Z-1471-2015)Churchill Medical Systems, Inc.2015-04-21
8" Standard Bore Ext Set, Product Code: BN-481 Accessory device used to administer medical recall (Z-1472-2015)Churchill Medical Systems, Inc.2015-04-21
7" High Pressure Set with Bionector, Product Code: CMS-808 and CMS-808-1 Accessory device recall (Z-1473-2015)Churchill Medical Systems, Inc.2015-04-21
7" Standard Bore High Pressure Ext Set, Product Code: CMS-809 Accessory device used to adm recall (Z-1474-2015)Churchill Medical Systems, Inc.2015-04-21
7" Standard Bore High Pressure Ext Set, Product Code: CMS-809 Accessory device used to adm recall (Z-1475-2015)Churchill Medical Systems, Inc.2015-04-21
Bifurcated set with check vales and Bionectors, Product Code: BN-2082CV Accessory device u recall (Z-1476-2015)Churchill Medical Systems, Inc.2015-04-21
4" Trifurcated set with Bionectors and check valves, Product Code: BN-3082CV and BN-3083CV recall (Z-1477-2015)Churchill Medical Systems, Inc.2015-04-21
6" Trifurcated set with Bionectors, Product Code: BN-944 Accessory device used to administ recall (Z-1478-2015)Churchill Medical Systems, Inc.2015-04-21
AMS-530 7 Microbore Trifurcated Extension sets Product Usage: Intravascular administration recall (Z-0813-2014)Churchill Medical Systems, Inc.2014-01-23
Vygon 14 Microbore Extension Set with Bionector, CMS-814-1. The CMS-814-1 is a 14 inch ext recall (Z-2251-2013)Churchill Medical Systems, Inc.2013-09-18
Central Dressing Change Kit; AMS-8464CP- 6. Vygon Central Dressing Change Kit contains: 1 recall (Z-2252-2013)Churchill Medical Systems, Inc.2013-09-18
Lifeguard Infusion Set with Smartsite, 20Ga, 1, CLGY-2010 Huber type needle set used for t recall (Z-0914-2013)Churchill Medical Systems, Inc.2013-03-06
Churchill Medical Systems Winged Infusion Set, 22Ga, 1", Latex-Free Winged Infusion Set Pr recall (Z-1480-2012)Churchill Medical Systems, Inc.2012-05-01
Churchill Medical Latex-Free IV Start Kit Product Code: AMS-623ATLF The kit includes a tou recall (Z-3049-2011)Churchill Medical Systems, Inc.2011-08-22
WalkMed Infusion Triton 90" 20 drop IV Administration Set with 2 Needlefree Y-sites and Ba recall (Z-1319-2011)Churchill Medical Systems, Inc.2011-02-16
WalkMed Infusion Triton 90" 20 drop IV Administration Set with Needlefree Y-site Item # T0 recall (Z-1320-2011)Churchill Medical Systems, Inc.2011-02-16
WalkMed Infusion Triton 90" 20 drop IV Administration Set with Needlefree Y-site and 0.22 recall (Z-1321-2011)Churchill Medical Systems, Inc.2011-02-16
WalkMed Infusion Triton 90" 20 drop IV Administration Set; Manufactured for Walked Infusio recall (Z-1322-2011)Churchill Medical Systems, Inc.2011-02-16
Churchill Medical Systems Central Line Dressing Kit; Item # AMS-8316CP-1 Intended use: Int recall (Z-1323-2011)Churchill Medical Systems, Inc.2011-02-16
WalkMed Infusion 100" 20 drop IV Administration Set with 1 Needlefree Y-site and Free Flow recall (Z-1324-2011)Churchill Medical Systems, Inc.2011-02-16
Churchill Medical 78" Stopcock Extension Set with male/female red cap; item # AMS-464-1 In recall (Z-1325-2011)Churchill Medical Systems, Inc.2011-02-16
Churchill Medical Systems 6" Microbore Trifurcated non-DEHP Extension Set with male/Female recall (Z-1326-2011)Churchill Medical Systems, Inc.2011-02-16
Churchill Medical Systems LifeGuard Non-Coring Huber Needle, Lifeguard Non-Coring Safety I recall (Z-1327-2011)Churchill Medical Systems, Inc.2011-02-16
Walkmed Infusion Triton 100" 20 Drop IV Administration Set with Free Flow Protection Clip; recall (Z-1328-2011)Churchill Medical Systems, Inc.2011-02-16
Churchill Medical Systems Fluid Transfer Set; Sterile Item # AMS-451 Intended use: Intrava recall (Z-1329-2011)Churchill Medical Systems, Inc.2011-02-16
Churchill Medical Systems 14"Extension Set with SmartSite Injection Item # 43000E Intended recall (Z-1330-2011)Churchill Medical Systems, Inc.2011-02-16
Churchill Medical Systems Central Line and Port Dressing Kit; Item AMS-8295CP-1 Intended u recall (Z-1331-2011)Churchill Medical Systems, Inc.2011-02-16
FMI 105"Oral Surgery Administration Set; Item AMS-468-1 Manufactured For: First Medical in recall (Z-1332-2011)Churchill Medical Systems, Inc.2011-02-16
Winged Infusion Set with 90 degree Huber Needle and Y Injection Site Distributed By: Flori recall (Z-1333-2011)Churchill Medical Systems, Inc.2011-02-16
Churchill Medical Systems Bag Access Device w/Smartsite Needleless Injection Site, Sterile recall (Z-1639-2010)Churchill Medical Systems, Inc.2010-05-21
Vygon Nutrisafe 2 syringe 5 ml, For Oral use only with Nutrisafe 2 Product Code: 1015.062M recall (Z-1203-2010)Churchill Medical Systems, Inc.2010-03-24
Vygon Nutrisafe 2 syringe 10 ml, Syringe for connection to Nutrisafe 2. For oral use only recall (Z-1204-2010)Churchill Medical Systems, Inc.2010-03-24

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Every clearance here is in the API, with alerts when new ones post.