PlainRecalls
FDA Devices Moderate Class II Terminated

BD Vacutainer CPT Cell Preparation Tube with Sodium Heparin, 8 mL, 16 x 125 mm, Catalog #REF 362753, Lot #4063409 with expiry 03/2015, intended for the collection of whole blood and the separation of mononuclear cells.

Reported: September 3, 2014 Initiated: July 3, 2014 #Z-2542-2014

Product Description

BD Vacutainer CPT Cell Preparation Tube with Sodium Heparin, 8 mL, 16 x 125 mm, Catalog #REF 362753, Lot #4063409 with expiry 03/2015, intended for the collection of whole blood and the separation of mononuclear cells.

Reason for Recall

BD has initiated the recall of its Vacutainer CPT Cell Preparation Tube due to poor separation, resulting in a reduced number of recovered mononuclear cells.

Details

Units Affected
296,160 tubes
Distribution
US and Foreign
Location
Franklin Lakes, NJ

Frequently Asked Questions

What product was recalled?
BD Vacutainer CPT Cell Preparation Tube with Sodium Heparin, 8 mL, 16 x 125 mm, Catalog #REF 362753, Lot #4063409 with expiry 03/2015, intended for the collection of whole blood and the separation of mononuclear cells.. Recalled by Becton Dickinson & Company. Units affected: 296,160 tubes.
Why was this product recalled?
BD has initiated the recall of its Vacutainer CPT Cell Preparation Tube due to poor separation, resulting in a reduced number of recovered mononuclear cells.
Which agency issued this recall?
This recall was issued by the FDA Devices on September 3, 2014. Severity: Moderate. Recall number: Z-2542-2014.