Home / Recalls / Churchill Medical Systems, Inc. / Z-0914-2013

Z-0914-2013 Class II Terminated

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

Recall Details

Product Type
Devices
Report Date
March 13, 2013
Initiation Date
January 21, 2013
Termination Date
September 10, 2013
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2340

Product Description

Lifeguard Infusion Set with Smartsite, 20Ga, 1, CLGY-2010 Huber type needle set used for the infusion of medical fluids into implantable ports.

Reason for Recall

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.

Distribution Pattern

Nationwide Distribution including MO, IL, FL, PA, VA, MO, NY, NE, NH, and OH.

Code Information

Lot #1210099

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-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)
  • Z-1476-2015 Class II — Bifurcated set with check vales and Bionectors, Product Code: BN-2082CV Accesso (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)