RecallRadar

FDA Device recall Z-2328-2017

Single-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter, Catheter, Percutaneous The Arrow Single-Lumen Catheter permi…

On 2017-06-21 the FDA classified a Class II recall of Single-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter, Catheter, Percutaneous The Arrow Single-Lumen Catheter permi… by Arrow International, citing arrow International is recalling the affected product because the packaging may not be completely sealed, which may compromise sterility.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-2328-2017
ClassificationClass II
Statusterminated
Initiated2017-05-09
Published2017-06-21
Last updated2026-09-13 11:54 UTC
CompanyArrow International
DistributionUS

Product

Single-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter, Catheter, Percutaneous The Arrow Single-Lumen Catheter permits venous access to the central circulation

Reason

Arrow International is recalling the affected product because the packaging may not be completely sealed, which may compromise sterility.

Identifiers

code_infoMaterial number: Ask-04301-WBH Device Listing D040650

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-2328-2017%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.