RecallRadar

FDA Device recall Z-0601-2018

ARROW PICC powered by ARROW VPS Stylet, Product Codes: CDC-35052-VPS and CDC-35041-VPS. Peripherally Inserted Central Catheter

On 2018-02-21 the FDA classified a Class II recall of ARROW PICC powered by ARROW VPS Stylet, Product Codes: CDC-35052-VPS and CDC-35041-VPS. Peripherally Inserted Central Catheter by Arrow International, citing finished good kits may contain incorrect components. Kits that should contain a 5 FR 2 lumen catheter may contain a 4 FR single lumen catheter and kits that should contain a 4 FR….

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0601-2018
ClassificationClass II
Statusterminated
Initiated2017-07-25
Published2018-02-21
Last updated2026-09-13 11:54 UTC
CompanyArrow International
DistributionUS

Product

ARROW PICC powered by ARROW VPS Stylet, Product Codes: CDC-35052-VPS and CDC-35041-VPS. Peripherally Inserted Central Catheter

Reason

Finished good kits may contain incorrect components. Kits that should contain a 5 FR 2 lumen catheter may contain a 4 FR single lumen catheter and kits that should contain a 4 FR single lumen catheter may contain a 5 FR 2 lumen catheter. This may cause a delay in treatment while a replacement catheter is obtained.

Identifiers

code_infoLot/Batch Numbers: 23F17A0038, 23F17A0040, 23F16M0059.

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-0601-2018%22

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