Vacuette, Plastic Cannula HOLDEX, Ref 450216, Single packed, sterile, single use disposable tube holder with off center plastic cannula at the top and a stainless steel needle on the underside of the holder. It is intended for use in routine specimen withdrawal from collection bags or bottles through needless cannula ports.
Recall
- Recall Number
- Z-2134-2008
- Event Number
- 48455
- Firm
- Greiner Bio-One North America, Inc.
- FEI Number
- 3001451379
- Product Code
- FMI
- Status
- Terminated
- Root Cause
- Device Design
- Initiated
- May 16, 2008
- Posted
- September 11, 2008
- Terminated
- August 21, 2009
- Address
- 4238 Capital Dr, Monroe, NC, 28110-7681
Description
Vacuette, Plastic Cannula HOLDEX, Ref 450216, Single packed, sterile, single use disposable tube holder with off center plastic cannula at the top and a stainless steel needle on the underside of the holder. It is intended for use in routine specimen withdrawal from collection bags or bottles through needless cannula ports.
At removal of the tube from the holder the needle may dislodge and become stuck in the tube stopper with the blunt end of the needle facing out.
Consignees were notified by letter on/about 05/16/2008. They were instructed to stop distributing the affected lots immediately and destroy any of the product they may have. A Product Disposition form was attached to be completed and returned via fax to Greiner bio-one. Consignees instructed to notify their customers and to provide Greiner bio-one with a list of their customers that have received the item. If you have any questions contact Manfred Abel at 704-261-7823.
Class II Recall - Nationwide Distribution.
1,606,005 units