Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0708-2008

Caspar Titanium Aneurysm Clip Appliers, Catalog No/Part #: FT420T, Casper Applier F/Mini Ti-Clipsstr 146 mm...

Aesculap Inc / initiated 2007-11-01 / Terminated / root cause: design

Aesculap Inc began a recall of Caspar Titanium Aneurysm Clip Appliers, Catalog No/Part #: FT420T, Casper Applier F/Mini Ti-Clipsstr 146 mm, Aesculap, Inc., Center Valley, PA. 18034 on . The reason FDA records is "Breakage: the inner rod of the applier may corrode and break". As of , the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number
Z-0708-2008
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Aesculap Inc
Product
Caspar Titanium Aneurysm Clip Appliers, Catalog No/Part #: FT420T, Casper Applier F/Mini Ti-Clipsstr 146 mm, Aesculap, Inc., Center Valley, PA. 18034
Product code
HCI Applier, Aneurysm Clip
Reason for recall
Breakage: the inner rod of the applier may corrode and break
Root cause tag
design
FDA root cause
Device Design
Action
The recalling firm issued an Import Recall Notice, on or about December 18, 2007, to all their customers to inform them of the problem and the need to return the devices .
Quantity in commerce
60 clips
Distribution
Worldwide- USA hospitals in AZ, CA, CO, IL, KY, MI, MS, ND, NM, NY, OH, OK, PA, TX, VA, WA, and WI, to sales representatives in NC, OK, and MO and shipped to distributors in CA and Canada.
Product codes and lots
Part #: FT420T