Skip to content
Recall Observatory FDA recall evidence

Device product

AGB+ Multi Lumen Central Venous Catheterization Kit; Product Codes: CDC-42703-XP1A and CDC-47702-XP1A; Exp. Dates Feb 2018 - Nov 2018

Z-0655-2018

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-0655-2018

Official wording

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

Code information: Lot numbers: Product Codes CDC-42703-XP1A: 23F16M0507 Product Code CDC-47702-XP1A: 23F17A0533

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).