Vacutainer(R) Brand Plus Pst(Tm) Plasma Separation Tube

• 7 recalls, same reason

  • Terminated Z-2308-2019 FDA Class II ·initiated 12 Jun 2019
  • Terminated Z-2300-2019 FDA Class II ·initiated 12 Jun 2019
  • Terminated Z-2301-2019 FDA Class II ·initiated 12 Jun 2019
  • Terminated Z-2304-2019 FDA Class II ·initiated 12 Jun 2019
  • Terminated Z-2305-2019 FDA Class II ·initiated 12 Jun 2019
  • Terminated Z-2302-2019 FDA Class II ·initiated 12 Jun 2019
  • Terminated Z-2303-2019 FDA Class II ·initiated 12 Jun 2019

  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.

• • Terminated Z-1746-2017 FDA Class II ·initiated 16 Mar 2017

  BD is initiating this product correction of multiple lots of BD Vacutainer Buffered Sodium Citrate: (9NC) Blood Collection Tube (13x75 mm x 4.5 mL). A limited number of tubes in these lots may exhibit stopper pullout from the tube as the user removes the needle from the stopper following specimen collection.

• • Terminated Z-1189-2017 FDA Class II ·initiated 16 Jan 2017

  A portion of this lot of blood collection tubes was manufactured with approximately twice the expected amount of buffered sodium citrate additive, an anticoagulant.

• • Terminated Z-0911-2013 FDA Class III ·initiated 5 Mar 2012

  BD is conducting a recall of the BD Vacutainer Plus Plastic Plasma Separator Tube (PST) with Light Green/BD Homogard Closure due to a deformed top of the tube reservoir reported in two customer complaints.

510(k) Number

K945952 ↗

FDA Product Code

JKA

Device Class

Class II

Regulation

21 CFR Part 862.1675

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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  FDA 510(k) K854093 Active Cleared 12 Nov 1985

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  FDA 510(k) K874427 Active Cleared 5 Jan 1988

• Sensicare Synthetic Medical Gloves

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  FDA 510(k) K915478 Active Cleared 27 Jan 1992

• Qbc Centrifugal Hematology Analyzer

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  FDA 510(k) K844645 Active Cleared 5 Mar 1985

• Holesterol Delta Test Assay

  Class I

  FDA 510(k) K771582 Active Cleared 13 Sep 1977

• Delta Test Triglycerides

  Class I

  FDA 510(k) K802136 Active Cleared 10 Oct 1980

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