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U.S. Department of Health and Human Services

Enforcement Report - Week of May 15, 2013

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Event Detail

Event ID 64736
Product Type Devices
Status Ongoing
Recalling Firm Cardinal Health, Medical Products & Services
City Park City
State IL
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-03-26
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern Distributed in the states of AR, MS, SC, and TN.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Presource PBDS, Total Knee, Kit, Circulator Catalog Number: PO24TKGWE01; Lots: 828654, 851596, 872322, 879459, 885132, 905305, 920462, 934298, 946652, 959208 Class I Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain outer plastic packaging on one or more components. If the packaging is removed without disassembling the components, remnants of the plastic from the packaging material may become lodged in the filter potentially causing an obstruction of airflow. 4,571 Kits total Z-1204-2013
Presource PBDS, Knee Arthroscopy, Kit, Circulator Catalog Number: PO24KAGWE01; Lots: 839276, 851503, 884374, 905171, 930617, 946381, 952446, 959782 Class I Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain outer plastic packaging on one or more components. If the packaging is removed without disassembling the components, remnants of the plastic from the packaging material may become lodged in the filter potentially causing an obstruction of airflow. 4,571 Kits total Z-1206-2013
Presource PBDS, Beaufort Memorial Hospital, Anesthesia Circuit, Kit Catalog Number:PZ23ANBUG; Lot: 200710 Class I Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain outer plastic packaging on one or more components. If the packaging is removed without disassembling the components, remnants of the plastic from the packaging material may become lodged in the filter potentially causing an obstruction of airflow. 4,571 Kits total Z-1205-2013
Presource PBDS, Total Joint, Kit, Circulator Catalog Number: PO24TJNPC01; Lots: 843134, 851291, 875033, 893475, 911751, 914529, 928726, 948543, 968125, Class I Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain outer plastic packaging on one or more components. If the packaging is removed without disassembling the components, remnants of the plastic from the packaging material may become lodged in the filter potentially causing an obstruction of airflow. 4,571 Kits total Z-1203-2013
Presource PBDS, Total Hip, Kit, Circulator Catalog Number: PO24THGWG01; Lots: 966051, 970753 Class I Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain outer plastic packaging on one or more components. If the packaging is removed without disassembling the components, remnants of the plastic from the packaging material may become lodged in the filter potentially causing an obstruction of airflow. 4,571 Kits total Z-1202-2013
Presource PBDS, Shoulder Procedure, Kit, Circulator Catalog Number: PO24SHNPC01; Lots: 843685, 864636, 875004, 893118, 901720, 924132, 934399, 959120, 968668 Class I Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain outer plastic packaging on one or more components. If the packaging is removed without disassembling the components, remnants of the plastic from the packaging material may become lodged in the filter potentially causing an obstruction of airflow. 4,571 Kits total Z-1201-2013
Presource PBDS, Shoulder Arthroscopy, Kit, Circulator Catalog Number: PO24SAGWF01; Lots: 847129, 877843, 905183, 931801, 935180, 946651, 957422, 969585 Class I Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain outer plastic packaging on one or more components. If the packaging is removed without disassembling the components, remnants of the plastic from the packaging material may become lodged in the filter potentially causing an obstruction of airflow. 4,571 Kits total Z-1200-2013
Presource PBDS, Hand, Kit, Circulator Catalog Number: PO24HKGWG01; Lots: 856515, 875680, 894983, 905021, 929987, 932368, 946822, 954543, 968547 Class I Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain outer plastic packaging on one or more components. If the packaging is removed without disassembling the components, remnants of the plastic from the packaging material may become lodged in the filter potentially causing an obstruction of airflow. 4,571 Kits total Z-1199-2013
Presource PBDS, Extremity, Kit, Circulator Catalog Number: PO24EXNPD01; Lots: 852429, 868825, 883022, 896400, 914524, 929984, 941696, 954317 Class I Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain outer plastic packaging on one or more components. If the packaging is removed without disassembling the components, remnants of the plastic from the packaging material may become lodged in the filter potentially causing an obstruction of airflow. 4,571 Kits total Z-1198-2013
Presource PBDS, Knee Arthroscopy, Kit, Circulator Catalog Number: PO24AKNPC01; Lots: 851288, 877594, 901672, 917786, 948443, 972424 Class I Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain outer plastic packaging on one or more components. If the packaging is removed without disassembling the components, remnants of the plastic from the packaging material may become lodged in the filter potentially causing an obstruction of airflow. 4,571 Kits total Z-1197-2013
Presource PBDS, Major Abdominal, Kit, Circulator Catalog Number: PG24MANPC01; Lots: 840143, 857320, 871000, 882315, 900599, 928133, 942238, 952387, 964048 Class I Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain outer plastic packaging on one or more components. If the packaging is removed without disassembling the components, remnants of the plastic from the packaging material may become lodged in the filter potentially causing an obstruction of airflow. 4,571 Kits total Z-1196-2013
Presource PBDS, General Laparoscopy, Kit, Circulator Catalog Number: PG24LGNPC01; Lots: 147492, 152554, 160275, 165822, 173745, 180700, 186904, 195042, 205901, 836989 Class I Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain outer plastic packaging on one or more components. If the packaging is removed without disassembling the components, remnants of the plastic from the packaging material may become lodged in the filter potentially causing an obstruction of airflow. 4,571 Kits total Z-1195-2013
A) Presource PBDS, Lap Chole, Kit, Clean Up; B) Presource PBDS, Greenwood LeFlore Hosp, Lap Chole, Kit A) Catalog Number: PG24LCGWG02; Lots: 153502, 162892, 170494, 180482, , 88701, 193548, 198163, 206986; B) Catalog Number: PG24LCGWG; Lots:153502, 162892, 170494, 180482, 188701, 193548, 198163, 206986 Class I Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain outer plastic packaging on one or more components. If the packaging is removed without disassembling the components, remnants of the plastic from the packaging material may become lodged in the filter potentially causing an obstruction of airflow. 4,571 Kits total Z-1194-2013
Presource PBDS, Gyn Laparoscopy Kit, Circulator Catalog Number: PB24LSNPC01; Lots: 152737, 159630, 168459, 176674, 187217, 197319, 840618 Class I Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain outer plastic packaging on one or more components. If the packaging is removed without disassembling the components, remnants of the plastic from the packaging material may become lodged in the filter potentially causing an obstruction of airflow. 4,571 Kits total Z-1193-2013
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