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Terminated

ARROW PICC powered by ARROW VPS Stylet

FDA Recall Z-0690-2018 · Posted None

Recalling FirmArrow International Inc
Recall StatusTerminated
Product CodeLJS
Date Initiated2017-10-17
Date Terminated2020-04-21
Product Quantity601 eaches

Reason for Recall

The kit may contain an incorrect catheter component. Kits that should contain a 40cm catheter may contain a 55cm catheter.

Firm Action

On October 17, 2017 an URGENT Medical Device Recall letter titled "ARROW PICC powered by ARROW VPS Stylet" was mailed to customers instructing them to review inventory and quarantine all affected product which will be returned to the firm. Questions or concerns can be directed to Customer Service at 18662466990.

Root Cause

Mixed-up of materials/components

Distribution Pattern

AZ, CA, GA, MA, MO, NY, VA

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K121941ARROW PICC POWERED BY ARROW VPS STYLETArrow International (Subsidiary of Teleflex Inc.) · 2012-09-07

Official Source

View FDA Recall →

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

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