Recall Z-2307-2019— Becton Dickinson & Company

Name: FDA recall Z-2307-2019
Creator: U.S. Food and Drug Administration
Published: 2019-06-12

Class II · Terminated

Class II FDA medical device recall by Becton Dickinson & Company, initiated 2019-06-12, terminated 2020-06-29. It names one FDA 510(k) clearance: K944566. Product: BD Vacutainer PST Gel and Lithium HeparinN (LH) 56 Units Blood Collection Tubes, Catalog Number 368056. Reason: False elevation of carboxyhemoglobin (COHb) results have been reported when using venous blood gas samples collected with tubes analyzed with the IL GEM 4000 instrument..

Recalling firm: Becton Dickinson & Company
Classification: Class II
Status: Terminated
Initiated: 2019-06-12
Terminated: 2020-06-29
Firm location: Franklin Lakes, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K944566 — VACUTAINER BRAND PLUS SODIUM HEPARIN TUBEBd Becton Dickinson Vacutainer Systems Preanalytic·cleared 1994-11-10

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 PST Gel and Lithium HeparinN (LH) 56 Units Blood Collection Tubes, Catalog Number 368056

Reason for recall

False elevation of carboxyhemoglobin (COHb) results have been reported when using venous blood gas samples collected with tubes analyzed with the IL GEM 4000 instrument.

Data sourced from openFDA. This site is unofficial and independent of the FDA.