Monoject(R) Trace Element Blood Collection Tube

• 3 recalls, same reason

  • Terminated Z-1570-2011 FDA Unclassified (pre-2012) ·initiated 15 Nov 2010
  • Terminated Z-1571-2011 FDA Unclassified (pre-2012) ·initiated 15 Nov 2010
  • Terminated Z-1569-2011 FDA Unclassified (pre-2012) ·initiated 15 Nov 2010

  The heparin sodium USP used to manufacture blood collection tubes was produced with crude heparin containing Over-Sulfated Chondroitin Sulfate.

510(k) Number

K883320 ↗

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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