PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: February 21, 2018 Initiated: July 25, 2017 #Z-0601-2018

Product Description

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

Reason for Recall

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.

Details

Recalling Firm
Arrow International Inc
Units Affected
2691 total
Distribution
US nationwide distribution.
Location
Reading, PA

Frequently Asked Questions

What product was recalled?
ARROW PICC powered by ARROW VPS Stylet, Product Codes: CDC-35052-VPS and CDC-35041-VPS. Peripherally Inserted Central Catheter. Recalled by Arrow International Inc. Units affected: 2691 total.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on February 21, 2018. Severity: Moderate. Recall number: Z-0601-2018.