Z-0658-2018 Class II Terminated
FDA device recall Z-0658-2018 was initiated by Arrow International Inc on October 17, 2017 and is designated Class II. Reason for recall: These finished good kits may contain the incorrect Springwire Guide (SWG). The recall status is terminated (terminated April 14, 2020). Affected quantity: 5,926 total.
Recall Details
- Product Type
- Devices
- Report Date
- February 28, 2018
- Initiation Date
- October 17, 2017
- Termination Date
- April 14, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5,926 total
Product 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 for Recall
These finished good kits may contain the incorrect Springwire Guide (SWG).
Distribution Pattern
Distribution US Nationwide
Code Information
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