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

S5-7604 Silicone Oil Injection Cannula 4mm Long - 20G REF 585246 High Viscosity Injectors are used during retinal surgery for fluid infusion. A High Viscosity Injector is placed into the sclera and temporarily sutured into place

FDA Recall Z-2163-2011 · Posted 2011-05-10

Recalling FirmBecton Dickinson and Company
Recall StatusTerminated
Product CodeHMX
Date Initiated2010-12-17
Date Terminated2013-07-03
Product Quantity1500 units

Reason for Recall

Restricted or no fluid flow for Visitec High Viscosity Injector.

Firm Action

Beaver Visitec (BVI) notified customers via telephone and by sending an Urgent Recall Customer Notification letter dated December 7, 2010. The letter identified the product, the problem, and the action to be taken by the customer. , Customers were requested to return all unused product in their inventory for credit or refund and complete the attached Customer Response Form and return it by fax to 781-893-7957. Questions can be directed to Inside Sales Manager at 781-906-7952.

Root Cause

Component change control

Distribution Pattern

Worldwide Distribution - USA (nationwide) and the countries of Israel, Jordan, Russia, Saudi Arabia, South Africa, Turkey, Iraq, Lebanon, Morocco, Tunisia, Syria, India, Argentina, Australia, Austria, New Zealand, China, UK, Germany, Russia, Belgium, Italy, France, Sweden, and Ireland.

Official Source

View FDA Recall →

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

↑