Bd Vacutainer Plus Plastic Urine C&S Preservayive Tubes and Kits

• 3 recalls, same reason

  • Terminated Z-1024-2010 FDA Unclassified (pre-2012) ·initiated 12 Oct 2009
  • Terminated Z-1023-2010 FDA Unclassified (pre-2012) ·initiated 12 Oct 2009
  • Terminated Z-1025-2010 FDA Unclassified (pre-2012) ·initiated 12 Oct 2009

  A small amount of discoloration was noted on Towelettes included in BD Vacutainer Urine collection kits. The entire kit components retain sterile interiors and no viable growth was detected on the towelettes.

510(k) Number

K024240 ↗

FDA Product Code

JSM

Device Class

Class I

Regulation

21 CFR Part 866.2390

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

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