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
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
