Home / Recalls / Churchill Medical Systems, Inc. / Z-1469-2015

Z-1469-2015 Class II Terminated

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

FDA device recall Z-1469-2015 was initiated by Churchill Medical Systems, Inc. on January 15, 2015 and is designated Class II. Reason for recall: Potential for leaking caused by insufficient bond between needleless device and female luer. The recall status is terminated (terminated February 25, 2016). Affected quantity: 2350.

Recall Details

Product Type: Devices
Report Date: April 29, 2015
Initiation Date: January 15, 2015
Termination Date: February 25, 2016
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 2350

Product Description

4" Microbore Double Lumen Set with Bionector, Product Code: BN-208 Accessory device used to administer medical fluids

Reason for Recall

Potential for leaking caused by insufficient bond between needleless device and female luer.

Distribution Pattern

Nationwide Distribution including TX, OH, NY, CA, UT, PA, MA, NY, VA, and IL.

Code Information

1303123 1305003 1305008 1305049 1306097

Other recalls by Churchill Medical Systems, Inc.

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-1477-2015 Class II — 4" Trifurcated set with Bionectors and check valves, Product Code: BN-3082CV and (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-1475-2015 Class II — 7" Standard Bore High Pressure Ext Set, Product Code: CMS-809 Accessory device (January 15, 2015)
Z-1476-2015 Class II — Bifurcated set with check vales and Bionectors, Product Code: BN-2082CV Accesso (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-1470-2015 Class II — 4" Microbore Trifurcated Ext set, Product Code: BN-308 Accessory device used to (January 15, 2015)
Z-1468-2015 Class II — Bifircated Extension Set, Product Code: BN-828 Accessory device used to adminis (January 15, 2015)
Z-1478-2015 Class II — 6" Trifurcated set with Bionectors, Product Code: BN-944 Accessory device used (January 15, 2015)