Device product

Pressure Injectable ARROWg+ard Blue PLUS MultiLumen Central Venous Catheterization Kit; Product Codes: ASK-45703-PNHS; ASK-45703-PGMCL; ASK-45703-PNW; Exp. Dates Feb 2018 - Nov 2018

Z-0649-2018

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-0649-2018

Official wording

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

Code information: Lot numbers: Product Code ASK-45703-PNHS: 23F16M0498 Product Code ASK-45703-PGMCL: 23F17A0505 Product Code ASK-45703-PNW: 23F17B0116

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).