Double-Swivel Connector

• 5 recalls, same reason

  • Terminated Z-1942-2009 FDA Unclassified (pre-2012) ·initiated 31 Jul 2009
  • Terminated Z-1943-2009 FDA Unclassified (pre-2012) ·initiated 31 Jul 2009
  • Terminated Z-1944-2009 FDA Unclassified (pre-2012) ·initiated 31 Jul 2009
  • Terminated Z-1941-2009 FDA Unclassified (pre-2012) ·initiated 31 Jul 2009
  • Terminated Z-1940-2009 FDA Unclassified (pre-2012) ·initiated 31 Jul 2009

  The tether attaching to the double swivel cap may partially or completely break at the attachment points, resulting in the potential of the accidental aspiration of the tether into the patient's lungs.

510(k) Number

K850964 ↗

FDA Product Code

BZA

Device Class

Class I

Regulation

21 CFR Part 868.5810

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

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