Stopcocks, Manifolds

• 3 recalls, same reason

  • Ongoing Z-2139-2026 FDA Class I ·initiated 24 Mar 2026
  • Ongoing Z-2138-2026 FDA Class I ·initiated 24 Mar 2026
  • Ongoing Z-2140-2026 FDA Class I ·initiated 24 Mar 2026

  Medline has identified the presence of particulate within the fluid path of the Manifolds.

• 2 recalls, same reason

  • Terminated Z-2574-2021 FDA Class II ·initiated 6 Aug 2021
  • Terminated Z-2575-2021 FDA Class II ·initiated 6 Aug 2021

  Potential for sterile barrier breach. Microscopic pinholes within the sterile pouch could potentially lead to non-sterile conditions.

• • Terminated Z-0287-2009 FDA Unclassified (pre-2012) ·initiated 6 Aug 2008 ·on shared 510(k) K782095

  Firm became aware that a specific batch of the product may contain loose plastic particulates in the fluid pathway.

• • Terminated Z-1393-05 FDA Unclassified (pre-2012) ·initiated 5 May 2004 ·on shared 510(k) K782095

  Molded handles used in Angiographic Manifolds may be occluded.

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

510(k) Number

K782095 ↗

FDA Product Code

DTL

Device Class

Class II

Regulation

21 CFR Part 870.4290

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Catheter, Arterial Line

  Class II

  FDA 510(k) K790083 Active Cleared 25 Jan 1979

• High Pressure Contrast Injection Line

  Class II

  FDA 510(k) K822100 Active Cleared 24 Aug 1982

• Arterial Extension Set

  Class II

  FDA 510(k) K790082 Active Cleared 25 Jan 1979

• Perceptor Compensator Morse Manifold

  Class II

  FDA 510(k) K951722 Active Cleared 25 Mar 1996

• Breeze Digital Inflation Device

  Class II

  FDA 510(k) K953676 Active Cleared 29 Mar 1996

• Continuous Flush Device

  Class II

  FDA 510(k) K813549 Active Cleared 12 Jan 1982

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