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U.S. Department of Health and Human Services

Enforcement Report - Week of November 13, 2013

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Product Detail

Product Description Portex® Saddleblock Tray with Drugs  25g Quincke; 4795-20 The Regional Anesthesia family of products is comprised of sterile (unless otherwise indicated in the product scope), single-use devices designed to perform epidural, spinal, combined epidural/spinal, nerve block, lumbar puncture and regional anesthesia procedures. The spinal products are comprised of spinal needles, introducer needles and accessories required to perform a spinal procedure.
Recall Number Z-0164-2014
Classification Class II
Code Info Lot: 2455104
Product Distributed Qty 222
Reason For Recall Visual particulate in the glass ampules of 5% Lidocaine HCL and 7.5% Dextrose Injection, USP, 2 mL Ampoule, NDC # 0409-4712-01, Hospira Lot Number 23-227-DK. These ampules are included in certain Portex Spinal Anaesthesia Trays.

Event Detail

Event Id 66351
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 2013-09-23
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide Distribution including AK, AR, AZ, CA, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NY, OH, OK, OR, PA, RI, SC, TX, UT, VA, VT, WA, WI, WY.