Recall Z-2542-2014— Becton Dickinson & Company
Class II · Terminated
Class II FDA medical device recall by Becton Dickinson & Company, initiated 2014-07-03, terminated 2016-05-03. It names 2 FDA 510(k) clearances: K911731, K891407. 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.. Reason: 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..
- Recalling firm
- Becton Dickinson & Company
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-07-03
- Terminated
- 2016-05-03
- Firm location
- Franklin Lakes, NJ, United States
510(k) clearances named in this recall
2 on FDA's record- K911731 — LEUCOPREP(R) BRAND CELL SEPARAT TUBE W/SODIUM CITR
- K891407 — LEUCOPREP CELL SEPARATION TUBE
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.