Z-2542-2014Class II

BD Vacutainer CPT Cell Preparation Tube with Sodium Heparin, 8 mL, 16 x 125 mm, Catalog #REF 362753, Lot...

Name: Z-2542-2014 BD Vacutainer CPT Cell Preparation Tube with Sodium Heparin, 8 mL, 16 x 125 mm, Catalog #REF 362753, Lot...
Creator: Becton Dickinson & Company
Published: 2014-07-03
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2014-07-03 / Terminated

FDA source

Becton Dickinson & Company began a recall of 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... on 2014-07-03. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2542-2014
Classification: Class II
Status: Terminated
Initiated: 2014-07-03
Posted: 2014-08-22
Terminated: 2016-05-03
Recalling firm: Becton Dickinson & Co
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.
Product code: JCF Lymphocyte Separation Medium
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.
FDA root cause: Under Investigation by firm
Action: BD issued an "Urgent Voluntary Product Recall" Letter dated July 3, 2014 and a "Notice of Return" Form to all affected customers.
Quantity in commerce: 296,160 tubes
Distribution: US and Foreign
Product codes and lots: 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, 8 mL, 16 x 125 mm, Lot #'s 4063410, 4063411, 4063415, 4063416, 4063417, 4063418 and 4063419 with expiry 03/15; Lot #'s 4090230, 4090232, 4090234 and 4090237 with expiry 04/15. Outside US D) REF #362780, 8 mL, 16 x 125 mm, Lot #'s 4063420 and 4063455 with expiry 03/15; Lot #'s 4090241 and 4090242 with expiry 04/15. E) REF #362781, 4 mL, 13 x 100 mm, Lot # 4063421 with expiry 03/15 F) REF #362782, 8 mL, 16 x 125 mm, Lot #'s 4063422 and 4063423 with expiry 03/15; Lot #'s 4090244 and 4090246 with expiry 04/15

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2542-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2542-2014	Class II	Terminated	Voluntary: Firm initiated	2014-09-03	2014-08-22

Product code JCF

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)