RecallDepth

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.

Company
Greiner Bio-One North America, Inc.
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

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.

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