Z-1314-2018Class II

Terumo Cardiovascular Procedure Kits containing Pall LG6NS LeukoGuard Leukocyte Reduction Arterial Blood...

Name: Z-1314-2018 Terumo Cardiovascular Procedure Kits containing Pall LG6NS LeukoGuard Leukocyte Reduction Arterial Blood...
Creator: Terumo Cardiovascular Systems Corp
Published: 2017-12-18
License: https://open.fda.gov/license/

Terumo Cardiovascular Systems Corporation / initiated 2017-12-18 / Terminated

FDA source

Terumo Cardiovascular Systems Corp began a recall of Terumo Cardiovascular Procedure Kits containing Pall LG6NS LeukoGuard Leukocyte Reduction Arterial Blood Filters. The Cardiovascular Procedure Kit containing... on 2017-12-18. FDA classified it as Class II and gives the reason as "Possible blood leaks through the hydrophobic portion of the Pall LG6NS LeukoGuard Leukocyte Reduction Arterial Blood Filters". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1314-2018
Classification: Class II
Status: Terminated
Initiated: 2017-12-18
Posted: 2018-04-06
Terminated: 2019-04-09
Recalling firm: Terumo Cardiovascular Systems Corporation
Product: Terumo Cardiovascular Procedure Kits containing Pall LG6NS LeukoGuard Leukocyte Reduction Arterial Blood Filters. The Cardiovascular Procedure Kit containing the Pall LG6NS LeukoGuard Leukocyte Reduction Arterial Blood Filter for Exhacorporeal Service is indicated for use only in the exhacorporeal circuit for cardiopulmonary bypass procedures for which the user designed it. The product is a sterile, disposable kit, intended for one time use for period up to 6 hours, after which it must be discarded in a manner which is within acceptable laws and practices. The Pall LG6NS LeukoGuard Leukocy1e Reduction Arterial Blood Filter for Exhacorporeal Service is designed to reduce the levels of circulating leucocy1es and exclude microemboli greater than 40 m in size from the perfu sate during exhacorporea l circulation. This included gas emboli, fat emboli and aggregates composed of platelets, red blood cells and other debris. The Pall LG6NS LeukoGuard Leukocyte Reduction Arterial Blood Filter can be included in Cardiovascular Procedure Kits (Convenience Kits). When the Pall LG6NS LeukoGuard Leukocyte Reduction Arterial Blood Filters is included in the Kits, the intended use of the filter remains unaffected.
Product code: OEZ Cardiovascular Procedure Kit
Reason for recall: Possible blood leaks through the hydrophobic portion of the Pall LG6NS LeukoGuard Leukocyte Reduction Arterial Blood Filters.
FDA root cause: Unknown/Undetermined by firm
Action: On December 18, 2017 a MEDICAL DEVICE RECALL letter was issued to customers with the specific lot codes and distribution dates listed on the customer response form. This letter requests customers to do the following: Review this Medical Device Recall Notice. Assure that all users receive notice of this issue. Refer to the Customer Response Form to identify your product that is subject to this action. Confirm receipt of this notification by completing and returning the attached Customer Response Form to the email address or fax number indicated on the form. Terumo CVS will issue a Returned Goods Authorization upon receipt of the Customer Response Form. Return all affected products to Terumo CVS. Questions or concerns can be directed to 1-800-521-2818
Quantity in commerce: 2677
Distribution: US Distribution to the states of : AL, OH, VA, NC, GA, NY, FL
Product codes and lots: 662143 735568 752561 767041 774364 775404 778816 783025 785629 794402 794411 735568

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1314-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1314-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-18	2018-04-06

Product code OEZ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)