—#162581

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.

FDA product code: OEZ — Cardiovascular Procedure Kit
Device class: Class 2
Medical specialty: Cardiovascular
Affected lot / code info: 662143 735568 752561 767041 774364 775404 778816 783025 785629 794402 794411 735568

Why it was recalled

Possible blood leaks through the hydrophobic portion of the Pall LG6NS LeukoGuard Leukocyte Reduction Arterial Blood Filters.

Root cause (FDA determination)

Unknown/Undetermined by firm

Action the firm took

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

Recalling firm

Firm: Terumo Cardiovascular Systems Corp
Address: 28 Howe St, Ashland, Massachusetts 01721-1305

Distribution

Distribution pattern: US Distribution to the states of : AL, OH, VA, NC, GA, NY, FL

Timeline

Recall initiated: 2017-12-18
Terminated: 2019-04-09
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #162581. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.