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U.S. Department of Health and Human Services

Enforcement Report - Week of September 25, 2013

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Product Detail

Product Description Vygon 14 Microbore Extension Set with Bionector, CMS-814-1. The CMS-814-1 is a 14 inch extension set used to administer IV fluids.
Recall Number Z-2251-2013
Classification Class II
Code Info 1203117, 1206030, 1212111, 1304133, 130516
Product Distributed Qty 13100
Reason For Recall Microbore tubing disconnecting from male luers on the extension sets.

Event Detail

Event Id 66060
Product Type Devices
Status Ongoing
Recalling Firm Churchill Medical Systems, Inc.
City Dover
State NH
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-08-12
Initial Firm Notification of Consignee or Public E-Mail
Distribution Pattern Nationwide Distribution (US), including the states of NY, MN, NJ, PA, FL, MD, and VA.
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