Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

Arrow Pressure Injectable PICC Powered by Arrow VPS Stylet Catalogue number CDC-35052-VPS, peripherally inserted central catheter.

FDA Recall Z-1494-2014 · Posted 2014-04-24

Recalling FirmArrow International Inc
Recall StatusTerminated
Product CodeLJS
Date Initiated2014-03-24
Date Terminated2015-09-21
Product Quantity789

Reason for Recall

Kits are packaged with the incorrect catheter. The kits contain a 40cm catheter and should contain a 50cm catheter.

Firm Action

A recall notification letter, dated March 24, 2014 was sent to end users. " Urgent Medical Device Recall Notification "

Root Cause

Labeling mix-ups

Distribution Pattern

Nationwide Distribution- Including the states of Az, Tn, Fl, Ga, Ca

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.

↑