Recall Z-1314-2018 ยท OEZ Cardiovascular Procedure Kit
Terumo Cardiovascular Systems Corp
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 steri
| Date | Dec 18, 2017 |
| Status | Terminated |
| Reason | Possible blood leaks through the hydrophobic portion of the Pall LG6NS LeukoGuard Leukocyte Reduction Arterial Blood Filters. |
| 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 Ret |
| Quantity | 2677 |
| Distribution | US Distribution to the states of : AL, OH, VA, NC, GA, NY, FL |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.