Recall Z-0292-2008
Medrad Inc · initiated October 25, 2007
Product
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
Codes / lots: Catalog Number : AVA500HC. Lot Numbers: 0906AACL01, 0906AACL02, 1006AACL01, 1006AACL02, 1006AACL03, 1106AACL01, 1106AACL03, 1106AACL04, 1106AACL05, 1206AACL01, 1206AACL02, 1206AACL03, 0107AACL01, 0107AACL02, 0107AACL03, 0107AACL04, 0107AACL05, 0107AACL06, 0207AACL01, 0307AACL01, 0307AACL02, 0307AACL03, 0407AACL01, 0407AACL02, 0507AACL01, 0507AACL02, 0607AACL01, 0607AACL02, 0607AACL03, and 0707AACL01.
Reason for recall
Sterility (package integrity) compromised: Incomplete package seal; sterility may be compromised
FDA-determined cause: Packaging process control
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.
Details
- Recall number
- Z-0292-2008
- Initiated
- October 25, 2007
- Posted by FDA
- December 11, 2007
- Terminated
- April 22, 2008
- Product code
- DXT – Injector And Syringe, Angiographic
- Quantity
- 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, Sweden, Portugal, Korea, Great Britain, Turkey and The United Arab Emerites.
- Recalling firm
- Medrad Inc, Indianola, PA