Bd Careflow Central Venous Catheter

• 2 recalls, same reason

  • Terminated Z-0629-05 FDA Unclassified (pre-2012) ·initiated 10 Jan 2005
  • Terminated Z-0630-05 FDA Unclassified (pre-2012) ·initiated 10 Jan 2005

  Various procedure trays and kits may have an insufficient seal, thus compromising sterility.

510(k) Number

K033500 ↗

FDA Product Code

FOZ

Device Class

Class II

Regulation

21 CFR Part 880.5200

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

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