1) ARROWg+ard Blue You-Blend Two-Lumen Hemodialysis Catheterization Kit for High Volume Infusions The large-bore two-lumen catheter permits venous access to the central circulation for rapid fluid administration, temporary or acute hemodialysis, apheresis and hemofiltration. It may be inserted into the jugular, subclavia, or femoral veins Catheter, hemodialysis non-implanted
FDA Recall Z-2334-2017 · Posted None
Recalling FirmArrow International Inc
Recall StatusTerminated
Product CodeMPB
Date Initiated2017-05-09
Date Terminated2018-09-17
Product Quantity27,485 units distributed in the U.S., 4,371 units distributed internationally
Reason for Recall
Arrow International is recalling the affected product because the packaging may not be completely sealed, which may compromise sterility.
Firm Action
Arrow International sent an Urgent Medical Device Recall Notification Letter dated May 11, 2017, to affected customers. The firm's notification letter is requesting that customers immediately assess their current inventory and to discontinue and quarantine any product with the specific lot codes listed in the letter. In addition, customers were asked to complete the Recall Acknowledgement form and fax or email it back to Customer Service so they can receive a Returns Good Authorization Number for the product's return. Customers with questions were instructed to contact their local sales representative or Customer Service at 1-866-246-6990.
Root Cause
Packaging
Distribution Pattern
Worldwide Distribution - US (nationwide) and Canada
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.