FDA Recall
Terminated
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
Recall: Z-0658-2018
·
Initiated October 17, 2017
Recall
- Recall Number
- Z-0658-2018
- Event Number
- 79197
- Firm
- Arrow International Inc
- FEI Number
- 3015859709
- Product Code
- MPB
- Status
- Terminated
- Root Cause
- Process control
- Initiated
- October 17, 2017
- Posted
- February 20, 2018
- Terminated
- April 14, 2020
- Address
- 2400 Bernville Rd, Reading, PA, 19605-9607
Description
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
Reason
These finished good kits may contain the incorrect Springwire Guide (SWG).
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.
Distribution
Distribution US Nationwide
Quantity
5,926 total