Elcam Stopcocks and Manifolds

• 5 recalls, same reason

  • Ongoing Z-0642-2026 FDA Class II ·initiated 29 Oct 2025
  • Ongoing Z-0644-2026 FDA Class II ·initiated 29 Oct 2025
  • Ongoing Z-0717-2026 FDA Class II ·initiated 29 Oct 2025
  • Ongoing Z-0641-2026 FDA Class II ·initiated 29 Oct 2025
  • Ongoing Z-0643-2026 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).

• • Ongoing Z-3144-2024 FDA Class II ·initiated 8 Aug 2024 ·on shared 510(k) K022895

  Potential for product leakage from the Spin Lock Connector on the distal end of the device due to the migration of excess solvent during the assembly process.

• 2 recalls, same reason

  • Terminated Z-0936-2020 FDA Class II ·initiated 20 Nov 2019 ·on shared 510(k) K022895
  • Terminated Z-0938-2020 FDA Class II ·initiated 20 Nov 2019 ·on shared 510(k) K022895

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

• 5 recalls, same reason

  • Terminated Z-0656-06 FDA Unclassified (pre-2012) ·initiated 15 Dec 2005
  • Terminated Z-0655-06 FDA Unclassified (pre-2012) ·initiated 15 Dec 2005
  • Terminated Z-0653-06 FDA Unclassified (pre-2012) ·initiated 15 Dec 2005
  • Terminated Z-0646-06 FDA Unclassified (pre-2012) ·initiated 15 Dec 2005
  • Terminated Z-0654-06 FDA Unclassified (pre-2012) ·initiated 15 Dec 2005

  The extension sets contain microbore female luers that may crack during use, resulting in leakage of medication or incomplete delivery of medication.

• • Terminated Z-0943-05 FDA Unclassified (pre-2012) ·initiated 21 Apr 2005

  There is an unsecure connection between the male Luer and the stopcock on the I.V. extension set.

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

510(k) Number

K022895 ↗

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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• Hemotec Act High Range Activated Clotting Time Open recall

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  FDA 510(k) K974164 Active Cleared 18 Dec 1997

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