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U.S. Department of Health and Human Services

Enforcement Report - Week of June 27, 2012

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Product Detail

Product Description Arrow International, Inc. 7FR 3-Lumen Arrowg+ard Blue Plus(R) Pressure Injectable Central Venous Catheter - Catalog number CDC-42703-XP1A The multiple-lumen pressure injectable catheter permits venous access to central circulation and injection of contrast media. The ARROWg+ard(R) antimicrobial surface is intended to provide protection against catheter-related infections.
Recall Number Z-1823-2012
Classification Class II
Code Info Lot number RF2033361
Product Distributed Qty 1,085
Reason For Recall Arrow is recalling the product due to the possibility of voids in the catheter hub which could lead to an interlumen crossover.

Event Detail

Event Id 62125
Product Type Devices
Status Ongoing
Recalling Firm Arrow International Inc
City Reading
State PA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-06-07
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern USA (nationwide) AL, AZ, AR, CA, CO, FL, GA, IL, IN, KS, LA, MA, MI, MO, NV, NH, NC, OH, PA, TX, VA, WA, and WI.
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