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U.S. Department of Health and Human Services

Enforcement Report - Week of October 2, 2013

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Event Detail

Event ID 65981
Product Type Devices
Status Ongoing
Recalling Firm Terumo Cardiovascular Systems Corporation
City Elkton
State MD
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-07-26
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern Nationwide Distribution including WA, IN, OK, TX, MI, CA, NY, CT, AZ, FL, WV, NC, VA, PA, TN, GA, AL, MA, SC, OH, MS, MO, SD, WI, AR, AND NV.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Terumo® Pall AL6X Arterial Blood Line Filter, labeled in part ***Terumo Cardiovascular Systems Corporation Elkton, MD 21921***, packaged as part of a Terumo Cardiovascular Procedure Kit or as a single, sterile filter unit Single/Sterile Terumo® Pall AL6X Arterial Filter: The Terumo Pall AL6X Arterial Filter is indicated for use in cardiopulmonary bypass procedures for the removal of micro-emboli greater than 40 microns in size, including gas emboli, fat emboli and aggregates composed of platelets, red blood cells and other debris from the arterial line and where the flow rate will not exceed 8 liters per minute. Cardiovascular Procedure (Convenience) Kit that includes the Terumo® Pall AL6X Arterial Filter: The Cardiovascular Procedure Kits are indicated for use only in the extracorporeal circuit for the cardiopulmonary bypass procedures for which the user designed. The sterile cardiovascular procedure kit is intended to be used one time for periods up to 6 hours. Recalled filters sold singly are identified with Part Number AL6X with the following lot codes: MM19, MN23, NC15, ND01, ND08, ND29, NE11, NE18, NE25, NF09, NF31, PA23, PD05, PE02, PF14, PF21, PG04, PG11, PG18, PG25, PH09, PH16, PH30, PK06, PK13, PL24, PM01, PM08, PM22, PM29, PN12, PN26, PP17, PP31, QA07, QA14, QA21, QC04, QC25, QD11, QD18, QD25, QE08, QE15, QE22, QE29, QF06, QF28, MM26, NL12, NM24, NP12, and PA30; Affected filters, also Part # AL6X, packaged within Terumo Cardiovascular Convenience Kits are identified with the following lot codes: PN19, QA14, QC11R, QD04, QE15, QF06, QF13, NM31, NP05, PC20, PD05, QF28, QC04, PD26, PG04, PE23R, PK13, PK20, QA21, QC11, QC11A, QD11, QE01, PL17, QE08, NK08, PG25, PN26, QC18, NN07, NN07R, PA16, PA16R, PC27, PC27R, PF07, PL24, PD12, PE09, PE30, PH09, PL10, PE23, PF14, PG18, PK06, PM01, PM22, PN12, QA02, QA28, QC25, QD25, NK01, NK08R, PH23, PH16, PL10A, PM15, PP10, PP17, QD18, QE22, NM17, NM17A, PC06, PC06R, PE09R, QE01A, QE15A, QE15T, QE15TA, QE15TC, QF13T, QF20, QF20T, NA10R, NA17R, ND14, ND28, ND28T, NE11T, NE18, NF23, NG06, NG20, NH11, NH18, NK15, NL12, NL26, NM03, NM10, NM24, NN14, NN28, NP12, PA30, PC13, PD19, PE16, PF07A, PF21, PK27, PK27A, PL04, PM08, PP03, QA14T, QE29, QF28T, QF28TA, PG11, PH30, PH30A, PN26A, QA07, NH25, NK29, PE02, PF29, PN19, QG17, PK13A, QD11A, MN22, NE25, NF31, PM29, PA09, QG03, PA02, PH23T, PG11T, QC18R, QF06A, PH09T, PH09TA, QF13TA, QF20TA, and QF20TC Class II Medical device used in cardiovascular procedures is defective. 15,817 filters Z-2261-2013
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