Z-0651-2018 Class II Terminated

Recalled by Arrow International Inc — Reading, PA

FDA device recall Z-0651-2018 was initiated by Arrow International Inc on October 17, 2017 and is designated Class II. Reason for recall: These finished good kits may contain the incorrect Springwire Guide (SWG). The recall status is terminated (terminated April 14, 2020). Affected quantity: 5,926 total.

Recall Details

Product Type
Devices
Report Date
February 28, 2018
Initiation Date
October 17, 2017
Termination Date
April 14, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
5,926 total

Product Description

Pressure Injectable Multi Lumen Central Venous Catheterization Kit with Blue FlexTip Catheter and Sharps Safety Features; Product Code: ASK-15703-PRWJ; Exp. Dates Feb 2018- Nov 2018

Reason for Recall

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

Distribution Pattern

Distribution US Nationwide

Code Information

Lot number: 13F17C0400