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Terminated

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

FDA Recall Z-0658-2018 · Posted 2018-02-20

Recalling FirmArrow International Inc
Recall StatusTerminated
Product CodeMPB
Date Initiated2017-10-17
Date Terminated2020-04-14
Product Quantity5,926 total

Reason for Recall

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

Firm Action

On October 17, 2017 an Urgent Medical Device recall letter from Arrow International was issued to customers requesting that customers review their inventory for product, which should immediately be discontinued and quarantined. The products are then to be returned to the firm. Questions or concerns can be directed to: Customer Service at 18662466990.

Root Cause

Process control

Distribution Pattern

Distribution US Nationwide

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K99393314 FR TWO-LUMEN HEMODIALYSIS CATHERIZATION KIT WITH BLUE FLEXTIP ARROWG+ARD BLUE CATHETER FOR HIGH VOLUME INFUSIONS, PROArrow Intl., Inc. · 2000-09-14

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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