FDA Enforcement
Class II
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
·
Reported February 28, 2018
Enforcement
- Recall Number
- Z-0658-2018
- Event ID
- 79197
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Arrow International Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- February 28, 2018
- Initiation Date
- October 17, 2017
- Classification Date
- February 20, 2018
- Termination Date
- April 14, 2020
- Address
- 2400 Bernville Rd, N/A, Reading, PA, 19605-9607, United States
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).
Code Info
Lot numbers: Product Code AK-22142-CDC: 13F17A0021 13F17A0315 Product Code AK-22142-F: 13F17B0338 13F17E0067 Product Code AK-25142-CDC: 13F17E0340 Product Code AK-25142-F: 13F17A0207
Distribution
Distribution US Nationwide
Quantity
5,926 total