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Terminated

Medrad Avanta Multi-Patient Disposable Hand Controller, Angiographic Injector and Syringe. Catalog number AVA 500 HC, For Use with MEDRAD Avant Fluid Management System, MEDRAD, Inc., Indianola, PA 15051

FDA Recall Z-0292-2008 · Posted 2007-12-11

Recalling FirmMedrad Inc
Recall StatusTerminated
Product CodeDXT
Date Initiated2007-10-25
Date Terminated2008-04-22
Product Quantity25, 977 units

Reason for Recall

Sterility (package integrity) compromised: Incomplete package seal; sterility may be compromised

Firm Action

The recalling firm issued an Urgent Medical Device Field Correction Letter dated 10/25/07 via Federal Express to their customers informing them of the problem. Customers can either return the product or consistent with the indicated use and established pratice of sheathing, utilize sterile sheaths with the hand controllers for up to five patients. Each letter is being accompanied by a box of 25 sheaths.

Root Cause

Packaging process control

Distribution Pattern

Worldwide-USA and countries of Germany, Israel, Finalnd, Italy, Netherland, Austria, France, Japan, Denmark, Ireland, South Africia, Australia, Saudi Arabia, Singapore, Canada, New Zealand, Spain, Sweden, Portugal, Korea, Great Britain, Turkey and The United Arab Emerites.

Official Source

View FDA Recall →

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

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