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U.S. Department of Health and Human Services

Class 2 Device Recall Terumo Pall AL6X Arterial Blood Line Filter

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 Class 2 Recall
Terumo Pall AL6X Arterial Blood Line Filter
see related information
Date Posted September 20, 2013
Recall Status1 Open
Recall Number Z-2261-2013
Recall Event ID 65981
Premarket Notification
510(K) Number
K083834 
Product Classification Filter, Blood, Cardiopulmonary Bypass, Arterial Line - Product Code DTM
Product 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.
Code Information 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
Recalling Firm/
Manufacturer
Terumo Cardiovascular Systems Corporation
125 Blue Ball Rd
Elkton, Maryland 21921-5315
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact Terumo CVS Customer Service:
800-521-2818
Manufacturer Reason
for Recall
Medical device used in cardiovascular procedures is defective.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
Action Terumo Cardiovascuolar Services sent recall letters to Chief of Perfusion, Director of Operating Room Services, Director of Biomedical Services, and Risk Management departments on July 26, 2013. The notifications advised that filters are being recalled because some of the filters may exhibit a partial or full occlusion of an outlet or purge port. Terumo CVS advised users to stop using Terumo AL6X arterial filters from the affected lot numbers for replacement. A supply of replacement filters for customer's immediate use accompanied the notification. For users ordering the AL6X filters as part of a Cardiovascular Procedure Kit, Terumo CVS is providing a preliminary supply of replacement Terumo AL6X arterial filters in which users may follow the instructions to replace the filter or users may return the Cardiovascular Procedure Kit and Terumo CVS will replace the filter for them. Customers with questions were advised to contact Terumo CVS Customer Service at 800-521-2818. For questions regarding this recall call 800-521-2818.
Quantity in Commerce 15,817 filters
Distribution 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.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = DTM and Original Applicant = TERUMO CARDIOVASCULAR SYSTEMS CORP.
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