RecallRadar

FDA Device recall Z-0658-2018

ARROWg+ard Blue Two Lumen Hemodialysis Catheterization Kit for High Volume Infusions

On 2018-02-28 the FDA classified a Class II recall of ARROWg+ard Blue Two Lumen Hemodialysis Catheterization Kit for High Volume Infusions by Arrow International, citing these finished good kits may contain the incorrect Springwire Guide (SWG).

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0658-2018
ClassificationClass II
Statusterminated
Initiated2017-10-17
Published2018-02-28
Last updated2026-09-13 11:54 UTC
CompanyArrow International
DistributionUS

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

Reason

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

Identifiers

code_info
Lot numbers: Product Code AK-22142-CDC: 13F17A0021 13F17A0315 Product Code AK-22142-F: 13F17B0338 13F17E0067…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

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0658-2018%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.