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

Z-0813-2014 Class II Terminated

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

FDA device recall Z-0813-2014 was initiated by Churchill Medical Systems, Inc. on January 7, 2014 and is designated Class II. Reason for recall: Defective component may cause extension sets to leak. The recall status is terminated (terminated November 3, 2014). Affected quantity: 3850.

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-1472-2015 Class II — 8" Standard Bore Ext Set, Product Code: BN-481 Accessory device used to adminis (January 15, 2015)
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Z-1477-2015 Class II — 4" Trifurcated set with Bionectors and check valves, Product Code: BN-3082CV and (January 15, 2015)
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Z-1478-2015 Class II — 6" Trifurcated set with Bionectors, Product Code: BN-944 Accessory device used (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-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)