Recall Z-0658-2018 ยท MPB Catheter, Hemodialysis, Non-Implanted
Arrow International Inc
ARROWg+ard Blue Two Lumen Hemodialysis Catheterization Kit for High Volume Infusions; Product Codes: AK-22142-CDC, AK-22142-F, AK-25142-CDC, AK-25142-F; Exp. Dates Feb 2018 - Nov 2018
| Date | Feb 20, 2018 (initiated Oct 17, 2017) |
| Status | Terminated |
| Reason | These finished good kits may contain the incorrect Springwire Guide (SWG). |
| Root cause | Process control |
| Action | On October 17, 2017 an Urgent Medical Device recall letter from Arrow International was issued to customers requesting that customers review their inventory for product, which should immediately be discontinued and quarantined. The products are then to be returned to the firm. Questions or concerns can be directed to: Customer Service at 18662466990. |
| Quantity | 5,926 total |
| Distribution | Distribution US Nationwide |
| 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 |