Churchill Medical Systems, Inc.
United StatesFDA applicant, unverified
- Devices
- 12
- FDA recalls
- 36
At a glance
Market reach
- United States
- FDA recalls
Catalogue
Search and filter all 12 devicesFDA recalls
2015
- 15 Jan 2015 Z-1467-2015 Class II Terminated Potential for leaking caused by insufficient bond between needleless device and female luer.
- 15 Jan 2015 Z-1468-2015 Class II Terminated Potential for leaking caused by insufficient bond between needleless device and female luer.
- 15 Jan 2015 Z-1469-2015 Class II Terminated Potential for leaking caused by insufficient bond between needleless device and female luer.
- 15 Jan 2015 Z-1470-2015 Class II Terminated Potential for leaking caused by insufficient bond between needleless device and female luer.
- 15 Jan 2015 Z-1471-2015 Class II Terminated Potential for leaking caused by insufficient bond between needleless device and female luer.
- 15 Jan 2015 Z-1472-2015 Class II Terminated Potential for leaking caused by insufficient bond between needleless device and female luer.
- 15 Jan 2015 Z-1473-2015 Class II Terminated Potential for leaking caused by insufficient bond between needleless device and female luer.
- 15 Jan 2015 Z-1474-2015 Class II Terminated Potential for leaking caused by insufficient bond between needleless device and female luer.
- 15 Jan 2015 Z-1475-2015 Class II Terminated Potential for leaking caused by insufficient bond between needleless device and female luer.
- 15 Jan 2015 Z-1476-2015 Class II Terminated Potential for leaking caused by insufficient bond between needleless device and female luer.
Show the 25 most recent of 36 recalls
2015
- 15 Jan 2015 Z-1477-2015 Class II Terminated Potential for leaking caused by insufficient bond between needleless device and female luer.
- 15 Jan 2015 Z-1478-2015 Class II Terminated Potential for leaking caused by insufficient bond between needleless device and female luer.
2014
- 7 Jan 2014 Z-0813-2014 Class II Terminated Defective component may cause extension sets to leak.
2013
- 12 Aug 2013 Z-2251-2013 Class II Terminated Microbore tubing disconnecting from male luers on the extension sets.
- 12 Aug 2013 Z-2252-2013 Class II Terminated Microbore tubing disconnecting from male luers on the extension sets.
- 21 Jan 2013 Z-0914-2013 Class II Terminated The label on the device states that the item number is CLGY-2210 when the item number on the device label should read CLGY-2010. This is a 20Ga Huber needle set; however, the product label states the pouch contains a 22Ga set.
2012
- 16 Apr 2012 Z-1480-2012 Not yet classified Terminated Mislabeled: MBS-2210 code on case label -22Ga Winged Infusion Set, ; however, the product label states 20Ga MBS-2010 code listed on device label.
2011
- 15 Jul 2011 Z-3049-2011 Unclassified (pre-2012) Terminated Outer Kit labeled expiration date longer than the expiration of the shortest expired product
2010
- 16 Nov 2010 Z-1319-2011 Unclassified (pre-2012) Terminated Routine testing conducted to challenge the success of sterilization was not fully completed for sterile products.
- 16 Nov 2010 Z-1320-2011 Unclassified (pre-2012) Terminated Routine testing conducted to challenge the success of sterilization was not fully completed for sterile products.
- 16 Nov 2010 Z-1321-2011 Unclassified (pre-2012) Terminated Routine testing conducted to challenge the success of sterilization was not fully completed for sterile products.
- 16 Nov 2010 Z-1322-2011 Unclassified (pre-2012) Terminated Routine testing conducted to challenge the success of sterilization was not fully completed for sterile products.
- 16 Nov 2010 Z-1323-2011 Unclassified (pre-2012) Terminated Routine testing conducted to challenge the success of sterilization was not fully completed for sterile products.
- 16 Nov 2010 Z-1324-2011 Unclassified (pre-2012) Terminated Routine testing conducted to challenge the success of sterilization was not fully completed for sterile products.
- 16 Nov 2010 Z-1325-2011 Unclassified (pre-2012) Terminated Routine testing conducted to challenge the success of sterilization was not fully completed for sterile products.
Frequently asked questions
How many devices does Churchill Medical Systems, Inc. have in the registry?
The registry currently lists 12 devices for Churchill Medical Systems, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Churchill Medical Systems, Inc.'s devices?
Among its 12 most recently registered devices, Churchill Medical Systems, Inc. has devices listed in FDA 510(k) (12 devices).
What risk classes do Churchill Medical Systems, Inc.'s devices fall under?
Among its 12 most recently registered devices, the classes recorded for Churchill Medical Systems, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Churchill Medical Systems, Inc.?
FDA recall records list 36 recalls initiated by Churchill Medical Systems, Inc., the most recent initiated on 15 Jan 2015. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Churchill Medical Systems, Inc. in the registry?
The most recently registered devices listed for Churchill Medical Systems, Inc. include 30 IV EXTENSION SET W/TWO MALE LUER LOCKS, CHURCHILL MEDICAL SYSTEMS STOPCOCK, CMS IV FILTERS and UNIVERSAL VIAL ACCESS SPIKE WITH NEEDLELESS CONNECTOR.