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U.S. Department of Health and Human Services

Enforcement Report - Week of March 19, 2014

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Product Detail

Product Description 4042E: 3 mL Line Draw, Luer lock syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro® device (for sale in Europe only) Arterial Blood Sampling Line Draw Syringes are sterile, single-use devices, in-vitro diagnostic devices used for the drawing of arterial blood via an arterial line. The product is not for injection.
Recall Number Z-1186-2014
Classification Class II
Code Info 2476326 2480611 2493966 2493967 2506812 2506813 2529537 2529539 2533321 2536818 2536820 2547286 2459794 2463880 2463881
Product Distributed Qty
Reason For Recall issue with the plunger tip of the Portex® Arterial Blood Sampling Line Draw Syringes

Event Detail

Event Id 66837
Product Type Devices
Status Ongoing
Recalling Firm Smiths Medical ASD, Inc.
City Keene
State NH
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-11-22
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Worldwide Distribution - USA including AL, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV. Internationally to Australia, Austria, Belgium, Belize, Brazil, Canada, Czech Republic, Denmark, England, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Netherlands, Norway, Poland, Scotland, Spain, and Sweden.
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