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

Arrowg+ard Blue Two Lumen CVC Super Kit, Catalog number AK-22802-SK. The kit actually contains Arrowg+ard Blue Plus Two Lumen CVC Super Kit. Catalog number AK-42802-SK, 8 Fr x 16 cm Two Lumen Arrowg+ard Blue Plus Catheters. The plus indicates that the line extension clamps are attached to the catheters.

FDA Recall Z-0059-05 · Posted 2004-10-28

Recalling FirmArrow International Inc
Recall StatusTerminated
Product CodeFOZ
Date Initiated2004-09-27
Date Terminated2004-11-30
Product Quantity290 kits

Reason for Recall

Labeling error. Kits contains the correct components for AK-42802-SK but may have a package label indicating that it is product number AK-22802-SK

Firm Action

The recalling firm issued a recall letter dated 9/27/04 to their accounts informing them of the problem and the need to return the product.

Root Cause

Other

Distribution Pattern

The products were shipped to distributors in KS and VA, medical facilities in AR, FL, and GA, and a sales representative in FL.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K993691ARROWG +ARD BLUE PLUS ANTIMICROBIAL MULTI-LUMEN CENTRAL VENOUS CATHETERArrow Intl., Inc. · 2000-03-08

Official Source

View FDA Recall →

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

↑