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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.

FDA Recall Z-2542-2014 · Posted 2014-08-22

Recalling FirmBecton Dickinson & Company
Recall StatusTerminated
Product CodeJCF
Date Initiated2014-07-03
Date Terminated2016-05-03
Product Quantity296,160 tubes

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.

Firm Action

BD issued an "Urgent Voluntary Product Recall" Letter dated July 3, 2014 and a "Notice of Return" Form to all affected customers.

Root Cause

Under Investigation by firm

Distribution Pattern

US and Foreign

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K911731LEUCOPREP(R) BRAND CELL SEPARAT TUBE W/SODIUM CITRBd Becton Dickinson Vacutainer Systems Preanalytic · 1992-12-15K891407LEUCOPREP CELL SEPARATION TUBEBd Becton Dickinson Vacutainer Systems Preanalytic · 1989-05-26

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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