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

1113 Gravity Tube Set Pk/24 -SH Product Usage: The FMS Gravity Tube Set is intended to deliver irrigation fluid from irrigation containers to the operative site during arthroscopic procedures.

FDA Recall Z-0695-2018 · Posted None

Recalling FirmDePuy Mitek, Inc., a Johnson & Johnson Co.
Recall StatusTerminated
Product CodeJCY
Date Initiated2017-08-31
Date Terminated2019-04-09
Product Quantity15,678

Reason for Recall

Leakage of FMS gravity tub sets (281113) at the bulb and tube connection

Firm Action

On September 6, 2017 an URGENT MEDICAL DEVICE RECALL letter was issued to customers titled "FMS Gravity Tubing" requesting that customers cease further distribution or use, quarantine all remaining products and contact sales consultant for the coordination of return and replacement. Questions or concerns can be directed to the recall coordinator at 508-828-6609

Root Cause

Nonconforming Material/Component

Distribution Pattern

US Nationwide Distribution

Official Source

View FDA Recall →

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

↑