Device product

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

Z-0658-2018

October 17, 2017

Class II

Product summary

Firm: Arrow International Inc
Event: Event 79197
Status: Terminated
Classification: Class II
Quantity: 5,926 total
Official record key: device-enforcement:Z-0658-2018

Official wording

Reason: These finished good kits may contain the incorrect Springwire Guide (SWG).

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

Distribution pattern: Distribution US Nationwide

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

These finished good kits may contain the incorrect Springwire Guide (SWG).