Terumo Pall AL6X Arterial Blood Line Filter — Class II medical device recall Z-2261-2013
Terminated recall by Terumo Cardiovascular Systems Corporation, reported 2013-10-02, distributed nationwide. Medical device used in cardiovascular procedures is defective.
| Recall number | Z-2261-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Terumo Cardiovascular Systems Corporation, Elkton, MD, United States |
| Recall initiated | 2013-07-26 |
| Classified | 2013-09-20 |
| Reported by FDA | 2013-10-02 |
| Terminated | 2015-07-28 |
| Distributed | Nationwide (US) |
| Quantity | 15,817 filters |
| Lot numbers | MM19, MM26, MN22, MN23, NA10R, NA17R, NC15, ND01, ND08, ND14, ND28, ND28T, ND29, NE11, NE11T, NE18, NE25, NF09, NF23, NF31, NG06, NG20, NH11, NH18, NH25, NK01, NK08, NK08R, NK15, NK29, NL12, NL26, NM03, NM10, NM17, NM17A, NM24, NM31, NN07, NN07R and 111 more |
| Model numbers | AL6X |
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.
Reason for recall
Medical device used in cardiovascular procedures is defective.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2261-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.