Filtered Extension Sets

• • Ongoing Z-0193-2027 FDA Not yet classified ·initiated 14 Sep 2026

  Potential for leakage and backflow at the Safsite valve.

• • Ongoing Z-3089-2026 FDA Class II ·initiated 4 Aug 2026

  Specific lots of Discofix Stopcock Sets recalled due to an incorrect expiration date printed on the carton shipper label.

• 15 recalls, same reason

  • Ongoing Z-0653-2026 FDA Class II ·initiated 29 Oct 2025
  • Ongoing Z-0692-2026 FDA Class II ·initiated 29 Oct 2025
  • Ongoing Z-0604-2026 FDA Class II ·initiated 29 Oct 2025
  • Ongoing Z-0663-2026 FDA Class II ·initiated 29 Oct 2025
  • Ongoing Z-0628-2026 FDA Class II ·initiated 29 Oct 2025
  • Ongoing Z-0704-2026 FDA Class II ·initiated 29 Oct 2025
  • Ongoing Z-0634-2026 FDA Class II ·initiated 29 Oct 2025
  • Ongoing Z-0633-2026 FDA Class II ·initiated 29 Oct 2025
  • Ongoing Z-0626-2026 FDA Class II ·initiated 29 Oct 2025
  • Ongoing Z-0703-2026 FDA Class II ·initiated 29 Oct 2025
  • Ongoing Z-0687-2026 FDA Class II ·initiated 29 Oct 2025
  • Ongoing Z-0716-2026 FDA Class II ·initiated 29 Oct 2025
  • Ongoing Z-0632-2026 FDA Class II ·initiated 29 Oct 2025
  • Ongoing Z-0715-2026 FDA Class II ·initiated 29 Oct 2025
  • Ongoing Z-0635-2026 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-0092-2023 FDA Class II ·initiated 15 Sep 2022

  The extension set has a high probability of potential failure which could lead to possible leakage or detachment at the device's bonded joint during use. The issue may result in delay of therapy, increased risk of bloodstream infections (BSI), and may expose both patients and healthcare workers to hazardous medications. Depending on the nature of the leak and type of infusion, there is also the potential for life-threatening situations to occur including air embolization or hypovolemia.

• • Ongoing Z-0091-2023 FDA Class II ·initiated 15 Sep 2022

  The extension set has a high probability of failure which could lead to possible leakage or detachment at the device's bonded joint during use. The issue may result in delay of therapy, increased risk of bloodstream infections (BSI), and may expose both patients and healthcare workers to hazardous medications. Depending on the nature of the leak and type of infusion, there is also the potential for life-threatening situations to occur including air embolization or hypovolemia.

• • Terminated Z-0727-2022 FDA Class II ·initiated 31 Jan 2022 ·on shared 510(k) K942988

  This lot may have an elevated risk of leakage from the Air-Inlet Filter of the device. Leakage of the Air-Inlet Filter may increase the risk of decreasing the dose of medication delivered to the patient, cause delays in treatment due to the need to replace the device or may cause contamination of the fluid path that can lead to bloodstream infection.

• 2 recalls, same reason

  • Terminated Z-2552-2021 FDA Class II ·initiated 10 Aug 2021
  • Terminated Z-2546-2021 FDA Class II ·initiated 10 Aug 2021

  Leakage of the pump set within the cassette portion of the pump sets, potential for delays in administration of medications, under-delivery or incomplete dosing and bloodstream infections.

• • Terminated Z-1509-2021 FDA Class II ·initiated 15 Mar 2021

  BBMI has identified through complaints the potential for the extension set to become occluded or unable to prime.

• • Terminated Z-2022-2014 FDA Class II ·initiated 29 May 2014

  Complaints were received that reported the stopcock of some Stopcock Extension Sets are assembled in the reverse position, resulting in the stopcock being closed when set in the open position and vise versa.

• • Terminated Z-0987-2014 FDA Class II ·initiated 8 Jan 2014

  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.

• 5 recalls, same reason

  • Terminated Z-0673-2010 FDA Unclassified (pre-2012) ·initiated 24 Nov 2009
  • Terminated Z-0670-2010 FDA Unclassified (pre-2012) ·initiated 24 Nov 2009
  • Terminated Z-0672-2010 FDA Unclassified (pre-2012) ·initiated 24 Nov 2009
  • Terminated Z-0671-2010 FDA Unclassified (pre-2012) ·initiated 24 Nov 2009
  • Terminated Z-0674-2010 FDA Unclassified (pre-2012) ·initiated 24 Nov 2009

  System error 9 alarms. A System Error 9 alarm indicates a potential pressure loss in the pump cassette delivery chamber (chamber closest to the patient). This alarm is generated during the pumps initiation sequence and will not allow the set to be used. This requires a new set to be obtained, thus creating a potential for delay in therapy.

• • Terminated Z-2408-2008 FDA Unclassified (pre-2012) ·initiated 30 Jun 2008 ·on shared 510(k) K942988

  incorrect burette was packaged with the product

• • Terminated Z-0933-03 FDA Unclassified (pre-2012) ·initiated 14 Apr 2003

  possible leakage

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

510(k) Number

K942988 ↗

FDA Product Code

FPA

Device Class

Class II

Regulation

21 CFR Part 880.5440

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Trumpet Valve

  Class II

  FDA 510(k) K911415 Active Cleared 3 Jun 1991

• Comfort-Q Subcutaneous Injection Sets

  Class II

  FDA 510(k) K946170 Active Cleared 3 Nov 1995

• Dualtherm(R) Cardiac Output Computer

  Class II

  FDA 510(k) K925285 Active Cleared 21 Jul 1993

• Charged Supor(R) Filter Extension Set

  Class II

  FDA 510(k) K940980 Active Cleared 14 Jul 1994

• Celsite Brachial Venous Port

  Class II

  FDA 510(k) K945752 Active Cleared 31 May 1995

• Celsite(Tm) Dual Venous System

  Class II

  FDA 510(k) K945551 Active Cleared 21 Apr 1995

See all devices from B. Braun of America, Inc. →