Stopcocks

• 3 recalls, same reason

  • Ongoing Z-0680-2026 FDA Class II ·initiated 29 Oct 2025
  • Ongoing Z-0679-2026 FDA Class II ·initiated 29 Oct 2025
  • Ongoing Z-0681-2026 FDA Class II ·initiated 29 Oct 2025

  Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

• • Terminated Z-0987-2014 FDA Class II ·initiated 8 Jan 2014 ·via K760383, on the same 510(k)

  Complaints were received reporting leakage on certain lots of SAFSITE Injection Sites and IV Sets manufactured with SAFSITE Injection Sites.The SAFSITE Injection Site is intended to provide needle free access on IV and Extension Sets.

• • Terminated Z-1432-2009 FDA Unclassified (pre-2012) ·initiated 27 Mar 2009 ·via K760383, on the same 510(k)

  Device defect is occlusion/no flow.

• • Terminated Z-0933-03 FDA Unclassified (pre-2012) ·initiated 14 Apr 2003 ·via K760383, on the same 510(k)

  possible leakage

Recalls marked "via" name another device cleared under the same FDA submission as this one.

510(k) Number

K760383 ↗

FDA Product Code

KGZ

Device Class

Class I

Regulation

21 CFR Part 878.4200

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Extension Sets

  Class I

  FDA 510(k) K760385 Active Cleared 2 Nov 1976

• Catheter, Vein (Venofix)

  Class II

  FDA 510(k) K760388 Active Cleared 2 Nov 1976

• Stoppers

  Class I

  FDA 510(k) K760384 Active Cleared 2 Nov 1976

• Cannula, Iv

  Class I

  FDA 510(k) K760389 Active Cleared 2 Nov 1976

• Connectors

  Class I

  FDA 510(k) K760382 Active Cleared 2 Nov 1976

• Central Veinous Pressure Sets

  Class II

  FDA 510(k) K760386 Active Cleared 2 Nov 1976

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