Terumo Cardiovascular Systems Corporation: Terumo Pall AL6X Arterial Blood Line Filter, labeled in part Terumo Cardiovascular Systems Corporation, 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.

Recall number

Z-2261-2013

Recalling firm

Terumo Cardiovascular Systems Corporation

Product

Terumo Pall AL6X Arterial Blood Line Filter, labeled in part Terumo Cardiovascular Systems Corporation, 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.

Status

Terminated

Initiated

2013-07-26

Posted

2013-09-20

Terminated

2015-07-28

Reason

Medical device used in cardiovascular procedures is defective.

Root cause

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

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.

Lot, serial or model codes

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

510(k) numbers

not on file

PMA numbers

not on file

Product code

DTM

Firm FEI

3000204839

Firm city

Elkton

Firm state

MD

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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