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U.S. Department of Health and Human Services

Class 2 Device Recall Cardiovascular Procedure Kits, Tubing Pack

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 Class 2 Device Recall Cardiovascular Procedure Kits, Tubing Packsee related information
Date Initiated by FirmDecember 18, 2017
Create DateApril 06, 2018
Recall Status1 Terminated 3 on April 09, 2019
Recall NumberZ-1314-2018
Recall Event ID 79524
Product Classification Cardiovascular procedure kit - Product Code OEZ
ProductTerumo 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.
Code Information 662143 735568 752561 767041 774364 775404 778816 783025 785629 794402 794411 735568 
Recalling Firm/
Manufacturer		 Terumo Cardiovascular Systems Corp
28 Howe St
Ashland MA 01721-1305
For Additional Information Contact
800-262-3304
Manufacturer Reason
for Recall		Possible blood leaks through the hydrophobic portion of the Pall LG6NS LeukoGuard Leukocyte Reduction Arterial Blood Filters.
FDA Determined
Cause 2		Unknown/Undetermined by firm
ActionOn 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 Commerce2677
DistributionUS Distribution to the states of : AL, OH, VA, NC, GA, NY, FL
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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