Medrad Avanta Multi-Patient Disposable Hand Controller, Angiographic Injector and Syringe. Catalog number AVA 500 HC, Fo

FDA device recall Z-0292-2008 · posted 2007-12-11 · Terminated

Recall details

Recalling firm

Medrad Inc

Reason for recall

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

Action taken

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

Status

Terminated

Product code

DXT

Quantity affected

25, 977 units

Distribution

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, Swe

Date initiated

2007-10-25

Date posted

2007-12-11

Date terminated

2008-04-22

Location

Indianola, PA