Events

Recall of Device Recall Terumo Pall AL6X Arterial Blood Line Filter

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Terumo Cardiovascular Systems Corporation.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    65981
  • Event Risk Class
    Class 2
  • Event Number
    Z-2261-2013
  • Event Initiated Date
    2013-07-26
  • Event Date Posted
    2013-09-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-07-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=121140
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Filter, blood, cardiopulmonary bypass, arterial line - Product Code DTM
  • Reason
    Medical device used in cardiovascular procedures is defective.
  • 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.

Device

Device Recall Terumo Pall AL6X Arterial Blood Line Filter
  • Model / Serial
    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
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • 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.
  • Product Description
    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.
  • Manufacturer
    Terumo Cardiovascular Systems Corporation

Manufacturer

Terumo Cardiovascular Systems Corporation
  • Manufacturer Address
    Terumo Cardiovascular Systems Corporation, 125 Blue Ball Rd, Elkton MD 21921-5315
  • Manufacturer Parent Company (2017)
    Terumo Corp.
  • Source
    USFDA