Churchill Medical Systems, Inc.
FDA Regulatory Profile
Churchill Medical Systems, Inc. appears in FDA public data with 16 recalls, 12 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1472-2015, Class II) was initiated on January 15, 2015. Its most recent 510(k) clearance was granted on December 21, 2004.
Summary
- Total Recalls
- 16
- 510(k) Clearances
- 12
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1472-2015 | Class II | 8" Standard Bore Ext Set, Product Code: BN-481 Accessory device used to administer medical fluids | January 15, 2015 |
| Z-1467-2015 | Class II | 6" Trifurcated Extension Set, Product Code: AMS-375-1 Accessory device used to administer medical f | January 15, 2015 |
| Z-1477-2015 | Class II | 4" Trifurcated set with Bionectors and check valves, Product Code: BN-3082CV and BN-3083CV Accessor | January 15, 2015 |
| Z-1475-2015 | Class II | 7" Standard Bore High Pressure Ext Set, Product Code: CMS-809 Accessory device used to administer m | January 15, 2015 |
| Z-1476-2015 | Class II | Bifurcated set with check vales and Bionectors, Product Code: BN-2082CV Accessory device used to ad | January 15, 2015 |
| Z-1469-2015 | Class II | 4" Microbore Double Lumen Set with Bionector, Product Code: BN-208 Accessory device used to adminis | January 15, 2015 |
| Z-1473-2015 | Class II | 7" High Pressure Set with Bionector, Product Code: CMS-808 and CMS-808-1 Accessory device used to a | January 15, 2015 |
| Z-1470-2015 | Class II | 4" Microbore Trifurcated Ext set, Product Code: BN-308 Accessory device used to administer medical | January 15, 2015 |
| Z-1468-2015 | Class II | Bifircated Extension Set, Product Code: BN-828 Accessory device used to administer medical fluids | January 15, 2015 |
| Z-1478-2015 | Class II | 6" Trifurcated set with Bionectors, Product Code: BN-944 Accessory device used to administer medica | January 15, 2015 |
| Z-1474-2015 | Class II | 7" Standard Bore High Pressure Ext Set, Product Code: CMS-809 Accessory device used to administer m | January 15, 2015 |
| Z-1471-2015 | Class II | 4" Microbore T-Port Set, Product Code: BN-448 Accessory device used to administer medical fluids | January 15, 2015 |
| Z-0813-2014 | Class II | AMS-530 7 Microbore Trifurcated Extension sets Product Usage: Intravascular administration se | January 7, 2014 |
| Z-2252-2013 | Class II | Central Dressing Change Kit; AMS-8464CP- 6. Vygon Central Dressing Change Kit contains: 1 Pair Nit | August 12, 2013 |
| Z-2251-2013 | Class II | Vygon 14 Microbore Extension Set with Bionector, CMS-814-1. The CMS-814-1 is a 14 inch extension set | August 12, 2013 |
| Z-0914-2013 | Class II | Lifeguard Infusion Set with Smartsite, 20Ga, 1, CLGY-2010 Huber type needle set used for the infu | January 21, 2013 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K041038 | CHURCHILL MEDICAL DUAL CHAMBER EMPTY CONTAINER | December 21, 2004 |
| K021395 | MODIFICATION TO 30 EXTENSION SET | May 13, 2002 |
| K013949 | UNIVERSAL VIAL ACCESS SPIKE WITH NEEDLELESS CONNECTOR | March 27, 2002 |
| K020544 | WING SAFE INFUSION SET 20 GA, SHS2000 SERIES; WING SAFE INFUSION SET 19 GA, SHS1900 SERIES; WING SAF | March 12, 2002 |
| K013950 | VENTED VIAL ACCESS DEVICE | January 10, 2002 |
| K012157 | CHURCHILL MEDICAL SYSTEMS STOPCOCK | September 11, 2001 |
| K011888 | PRESSURE ACTIVATED CHECK VALVE | September 10, 2001 |
| K011336 | PRIMARY SOLUTION SET WITH UNIVERSAL SPIKE, INJECTION SITE AND MALE LUER LOCK | June 12, 2001 |
| K896333 | CMS IV FILTERS | January 11, 1990 |
| K894954 | .22 & 1.2 MICRON IV FILTERS | November 13, 1989 |
| K884370 | CMS IV EXTENSION SETS | November 7, 1988 |
| K882503 | 30 IV EXTENSION SET W/TWO MALE LUER LOCKS | August 25, 1988 |