Closed Swabable Stopcock and Minimal Residual Volume Luer-Activated Swabable-Stopcock

• 11 recalls, same reason

  • Ongoing Z-0606-2026 FDA Class II ·initiated 29 Oct 2025
  • Ongoing Z-0650-2026 FDA Class II ·initiated 29 Oct 2025
  • Ongoing Z-0646-2026 FDA Class II ·initiated 29 Oct 2025
  • Ongoing Z-0651-2026 FDA Class II ·initiated 29 Oct 2025
  • Ongoing Z-0647-2026 FDA Class II ·initiated 29 Oct 2025
  • Ongoing Z-0608-2026 FDA Class II ·initiated 29 Oct 2025
  • Ongoing Z-0708-2026 FDA Class II ·initiated 29 Oct 2025
  • Ongoing Z-0645-2026 FDA Class II ·initiated 29 Oct 2025
  • Ongoing Z-0607-2026 FDA Class II ·initiated 29 Oct 2025
  • Ongoing Z-0648-2026 FDA Class II ·initiated 29 Oct 2025
  • Ongoing Z-0649-2026 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).

• 2 recalls, same reason

  • Terminated Z-0937-2020 FDA Class II ·initiated 20 Nov 2019 ·on shared 510(k) K060231
  • Terminated Z-0939-2020 FDA Class II ·initiated 20 Nov 2019 ·on shared 510(k) K060231

  Potential for leakage at the joint between the blood filters and tubing

• • Terminated Z-1869-2017 FDA Class II ·initiated 2 Feb 2017

  The stopcock was found to have punctures.

• • Terminated Z-0987-2014 FDA Class II ·initiated 8 Jan 2014 ·on shared 510(k) K060231

  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 ·on shared 510(k) K060231

  Device defect is occlusion/no flow.

• 4 recalls, same reason

  • Terminated Z-2207-2008 FDA Unclassified (pre-2012) ·initiated 11 Jun 2008
  • Terminated Z-2208-2008 FDA Unclassified (pre-2012) ·initiated 11 Jun 2008
  • Terminated Z-2205-2008 FDA Unclassified (pre-2012) ·initiated 11 Jun 2008
  • Terminated Z-2206-2008 FDA Unclassified (pre-2012) ·initiated 11 Jun 2008

  Improper orientation of the stopcock handle questions whether there is an adequate gas path to assure sterility, which presents a possible compromise of sterility.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K060231 ↗

FDA Product Code

FMG

Device Class

Class II

Regulation

21 CFR Part 880.5440

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

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