BD Vacutainer CPT Cell Preparation Tubes Recalled for Poor Separation
Becton Dickinson is recalling specific lots of BD Vacutainer CPT Cell Preparation Tubes due to poor separation that reduces the number of recovered mononuclear cells.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard is a performance defect (poor separation) that reduces cell recovery, but the source text does not report any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Becton Dickinson & Company has initiated a recall of its BD Vacutainer CPT Cell Preparation Tubes. The recall involves specific catalog numbers and lots of 8 mL and 4 mL tubes intended for the collection of whole blood and the separation of mononuclear cells. The total quantity affected is 296,160 tubes.
The reason for the recall is poor separation, which results in a reduced number of recovered mononuclear cells. This defect affects the performance of the device in its intended use for cell separation.
The affected products were distributed in the US and foreign markets. Users of these specific medical devices should stop using the affected lots and contact Becton Dickinson for further instructions or replacement.
The recalled product
- Product
- 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.
- Manufacturer
- Becton Dickinson & Company
- Affected units
- 296,160
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- A) REF #362753
- 8 mL
- 16 x 125 mm
- Lot #'s 4063409
- 4063413 and 4063414 with expiry 03/15
- Lot #'s 4090214
- 4090215 and 4090216 with expiry 04/15
- B) REF #362760
- 4 mL
- 13 x 100 mm
- Lot #4063412 with expiry 03/15
- C) REF #362761
- Lot #'s 4063410
- 4063411
- 4063415
- 4063416
- 4063417
- 4063418 and 4063419 with expiry 03/15
- Lot #'s 4090230
- 4090232
Distribution
Distribution scope not specified by the agency.
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