Tubing Connectors Ec-2XXX Series

• 18 recalls, same reason

  • Terminated Z-2455-2020 FDA Class II ·initiated 24 Apr 2020
  • Terminated Z-2460-2020 FDA Class II ·initiated 24 Apr 2020
  • Terminated Z-2448-2020 FDA Class II ·initiated 24 Apr 2020
  • Terminated Z-2443-2020 FDA Class II ·initiated 24 Apr 2020
  • Terminated Z-2452-2020 FDA Class II ·initiated 24 Apr 2020
  • Terminated Z-2449-2020 FDA Class II ·initiated 24 Apr 2020
  • Terminated Z-2457-2020 FDA Class II ·initiated 24 Apr 2020
  • Terminated Z-2456-2020 FDA Class II ·initiated 24 Apr 2020
  • Terminated Z-2445-2020 FDA Class II ·initiated 24 Apr 2020
  • Terminated Z-2451-2020 FDA Class II ·initiated 24 Apr 2020
  • Terminated Z-2461-2020 FDA Class II ·initiated 24 Apr 2020
  • Terminated Z-2444-2020 FDA Class II ·initiated 24 Apr 2020
  • Terminated Z-2450-2020 FDA Class II ·initiated 24 Apr 2020
  • Terminated Z-2454-2020 FDA Class II ·initiated 24 Apr 2020
  • Terminated Z-2446-2020 FDA Class II ·initiated 24 Apr 2020
  • Terminated Z-2462-2020 FDA Class II ·initiated 24 Apr 2020
  • Terminated Z-2458-2020 FDA Class II ·initiated 24 Apr 2020
  • Terminated Z-2447-2020 FDA Class II ·initiated 24 Apr 2020

  The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone Connectors may present a breach. The issue potentially affects component assembled with a specific packaging and is associated to a specific production period.

• • Terminated Z-2459-2020 FDA Class II ·initiated 24 Apr 2020

  XXX

• • Terminated Z-2642-2020 FDA Class III ·initiated 18 Nov 2019

  Some packages of sterile disposable connectors contained a 3/8x1/4 reducer instead of the specified 1/2x1/2 connector. No significant risk to health is expected as the issue is easily detectable and the different shape would prevent use of the connector.

• 2 recalls, same reason

  • Terminated Z-0157-2013 FDA Class II ·initiated 14 Sep 2012
  • Terminated Z-0158-2013 FDA Class II ·initiated 14 Sep 2012

  Due to a molding irregularity, certain lots of connectors have the potential to leak fluid or entrain air at the interface of the luer fitting and mating cap. Entrained air could result in patient injury.

510(k) Number

K833322 ↗

FDA Product Code

DTL

Device Class

Class II

Regulation

21 CFR Part 870.4290

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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  FDA 510(k) K854610 Active Cleared 8 May 1986

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  Class II

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• Chest Drainage Pack, CDP-1000

  Class II

  FDA 510(k) K861103 Active Cleared 28 May 1986

• Cardiotomy/Venous Reservoir No.: Cvr Series

  Class II

  FDA 510(k) K883923 Active Cleared 4 Nov 1988

• Atr-2900DF (with Depth Filter)/Cap-35DF (with Depth Filter)

  Class II

  FDA 510(k) K936286 Active Cleared 14 Feb 1994

• Blood Reservoir, Cardiopulmonary Bypass

  Class II

  FDA 510(k) K882414 Active Cleared 5 Dec 1988

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