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.
This recall has been terminated (originally issued September 11, 2008).
- Recall Initiated
- May 16, 2008
- Posted
- September 11, 2008
- Terminated
- August 21, 2009
- Recall Number
- Z-2134-2008
- Quantity
- 1,606,005 units
- Firm Location
- Monroe, NC
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
Class II Recall - Nationwide Distribution.
Lot / Code Info
Item #450216, Lot #A10074, A100745, A100746, A100747, A110749, and A110750.
Root Cause
Device Design
Action Taken
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.