LH Lithium Heparin tubes, Greiner bio-one, North America, 4238 Capital Drive, Monroe, NC 28110. Venous blood collection tubes.
- Recall Initiated
- December 14, 2011
- Posted
- February 22, 2012
- Terminated
- June 21, 2012
- Recall Number
- Z-1081-2012
- Quantity
- 2,082,000 pieces
- Firm Location
- Monroe, NC
Reason for Recall
The lithium heparin tubes may have a contamination with EDTA potassium.
Distribution
Nationwide Distribution.
Lot / Code Info
Item #456087, Lot #B07115 and B08116, Item #454244, #B091112, Item #456087CA, Lot #B091106, Item #456287, Lot #B101114, Item #454237, Lot #B091108 and Item #456287, Lot #B091110.
Root Cause
Material/Component Contamination
Action Taken
Greiner Bio-One sent a "RECALL OF LITHIUM HEPARIN TUBES WITH EDTA CONTAMINATION" letter dated December 13, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. The letter instructs customers to complete an attached Product Disposition Site Confirmation Form and to fax the form to 800-726-0052. This form will confirm that customers have discarded/destroyed all affected product. The firm will replace the product after receipt of the form. Contact the firm at 800-515-8112 for questions regarding this recall.