Home / Recalls / Churchill Medical Systems, Inc. / Z-0813-2014

Z-0813-2014 Class II Terminated

Recalled by Churchill Medical Systems, Inc. — Dover, NH

Recall Details

Product Type
Devices
Report Date
January 29, 2014
Initiation Date
January 7, 2014
Termination Date
November 3, 2014
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
3850

Product Description

AMS-530 7 Microbore Trifurcated Extension sets Product Usage: Intravascular administration set.

Reason for Recall

Defective component may cause extension sets to leak.

Distribution Pattern

US Nationwide Distribution in the states of: NY, VA, IL, MO, OR, FL, DE, OH

Code Information

Lot Number: 1306034, 1307011

Other recalls by Churchill Medical Systems, Inc.

  • Z-1477-2015 Class II — 4" Trifurcated set with Bionectors and check valves, Product Code: BN-3082CV and (January 15, 2015)
  • Z-1478-2015 Class II — 6" Trifurcated set with Bionectors, Product Code: BN-944 Accessory device used (January 15, 2015)
  • Z-1475-2015 Class II — 7" Standard Bore High Pressure Ext Set, Product Code: CMS-809 Accessory device (January 15, 2015)
  • Z-1469-2015 Class II — 4" Microbore Double Lumen Set with Bionector, Product Code: BN-208 Accessory de (January 15, 2015)
  • Z-1473-2015 Class II — 7" High Pressure Set with Bionector, Product Code: CMS-808 and CMS-808-1 Access (January 15, 2015)
  • Z-1472-2015 Class II — 8" Standard Bore Ext Set, Product Code: BN-481 Accessory device used to adminis (January 15, 2015)
  • Z-1467-2015 Class II — 6" Trifurcated Extension Set, Product Code: AMS-375-1 Accessory device used to (January 15, 2015)
  • Z-1470-2015 Class II — 4" Microbore Trifurcated Ext set, Product Code: BN-308 Accessory device used to (January 15, 2015)
  • Z-1474-2015 Class II — 7" Standard Bore High Pressure Ext Set, Product Code: CMS-809 Accessory device (January 15, 2015)
  • Z-1471-2015 Class II — 4" Microbore T-Port Set, Product Code: BN-448 Accessory device used to administ (January 15, 2015)