Recall Z-2334-2017 ยท MPB Catheter, Hemodialysis, Non-Implanted
Arrow International Inc
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
| Date | May 9, 2017 |
| Status | Terminated |
| Reason | Arrow International is recalling the affected product because the packaging may not be completely sealed, which may compromise sterility. |
| Root cause | Packaging |
| 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 re |
| Quantity | 27,485 units distributed in the U.S., 4,371 units distributed internationally |
| Distribution | Worldwide Distribution - US (nationwide) and Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K993933 | 14 FR TWO-LUMEN HEMODIALYSIS CATHERIZATION KIT WITH BLUE FLEXTIP ARROWG+ARD BLUE CATHETER FOR HIGH VOLUME INFUSIONS, PRO Arrow Intl., Inc., Sep 14, 2000 |