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

Henora REF: 70-4026-09V1 300psi I.V. Catheter Extension Set Product Usage: Catheter extension set for high pressure procedures.

FDA Recall Z-1996-2014 · Posted 2014-07-07

Recalling FirmRGI Medical Manufacturing, Inc.
Recall StatusTerminated
Product CodeFPA
Date Initiated2014-03-28
Date Terminated2016-09-29
Product Quantity19,200 units.

Reason for Recall

Problem with low adhesion of the tubing to luer connection which may lead to a separation of the extension set while in use.

Firm Action

RGI Medical Manufacturing, Inc. phoned their direct account: Baxter Healthcare on February 28, 2014 and sent an Urgent: Device Recall letter dated March 21, 2014. The letter identified the affected product, problem and the actions to be taken. Contact 800-747-6870 to obtain instruction for returning the product to RGI

Root Cause

Process control

Distribution Pattern

US Nationwide Distribution in the states of AL, CA, DE, GA, IL, KY, MA, MD, ME, MI, MN, NJ, NM, NV, NY, OH, TN, TX, WA, and WI.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K001599ACTI-FLEX IV ADMINISTRATION SETR-Group Intl. · 2000-09-18

Official Source

View FDA Recall →

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

↑