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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Terumo Cardiovascular Systems Corporation
- Reason for Recall:
- Medical device used in cardiovascular procedures is defective.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full 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.
Product Codes/Lot Numbers:
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
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2261-2013
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