Regional Anesthesia Trays

• • Ongoing Z-1101-2026 FDA Class II ·initiated 19 Dec 2025

  Affected lots of syringes may have a crack on the syringe collar, which may lead to delayed or repeated blood draw/fluid delivery. This issue may also lead to blood leakage during sampling of arterial blood or leakage during fluid delivery.

• • Terminated Z-0211-2007 FDA Unclassified (pre-2012) ·initiated 27 Oct 2006

  Misbranded: Tray label states 26G x 5/8 inch, needle is 25 G x 1 inch

• 4 recalls, same reason

  • Terminated Z-0244-06 FDA Unclassified (pre-2012) ·initiated 17 Nov 2005
  • Terminated Z-0245-06 FDA Unclassified (pre-2012) ·initiated 17 Nov 2005
  • Terminated Z-0242-06 FDA Unclassified (pre-2012) ·initiated 17 Nov 2005
  • Terminated Z-0243-06 FDA Unclassified (pre-2012) ·initiated 17 Nov 2005

  Tray may contain holes compromising the sterility of the device

• • Terminated Z-0166-04 FDA Unclassified (pre-2012) ·initiated 10 Oct 2003

  Spinal trays labeled as containing a Whitacre 25g x 3.5' needle actually contain a Quincke 25g x 3.5' needle.

510(k) Number

K965017 ↗

FDA Product Code

CAZ

Device Class

Class II

Regulation

21 CFR Part 868.5140

Advisory Committee

Anesthesiology

FDA Decision

SEKD

• Percutaneous Tracheostomy Kit

  Class II

  FDA 510(k) K936133 Active Cleared 23 Mar 1994

• Pro-Vent(Tm), Pulsator(R), and Line Draw(Tm) Arterial Blood Sampling Syringes

  Class II

  FDA 510(k) K945777 Active Cleared 22 Dec 1994

• Sims Cpap System

  Class II

  FDA 510(k) K953485 Active Cleared 26 Oct 1995

• Fenestrated Flexible D.I.C. Tracheostomy Tube Cuffed

  Class II

  FDA 510(k) K972385 Active Cleared 20 Jan 1998

• Pro-Vent, Line Draw, Pulsator Open recall

  Class II

  FDA 510(k) K952516 Active Cleared 14 Jul 1995

• Wallace IV Cannula

  Class II

  FDA 510(k) K932946 Active Cleared 1 Sep 1995

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