Portex 4041-2Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 20351688021448), received between May 14, 2024 and May 14, 2025 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Separation Problem” (3 reports).

31 other recalls cover devices cleared under the same FDA submission (K952516); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 14, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT BLOOD LEAKED FROM THE BLOOD GAS SYRINGE DUE TO THE CAP THAT CAME OFF. THE EVENT OCCURRED DURING TRANSIT. THERE WAS NO PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22018878 ↗
• MalfunctionMay 14, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT BLOOD LEAKED FROM THE BLOOD GAS SYRINGE DUE TO THE CAP THAT CAME OFF. THE EVENT OCCURRED DURING TRANSIT. THERE WAS NO PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22018874 ↗
• MalfunctionMar 18, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT SYRINGES WERE FREQUENTLY LEAKING BLOOD THROUGH THE TOP OF THE CAP. THE EVENT OCCURRED WHILE IN USE WITH A PATIENT WHEN BLOOD DRAW WAS COMPLETE AND HAPPENED ONCE BLOOD WAS PLACED IN THE SYRINGE. THERE WAS MEDICAL INTERVENTION REQUIRED AND ADDITIONAL BLOOD SAMPLE WAS NEEDED. THERE WAS NO PATIENT HARM OR ADVERSE EVENTS REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21638586 ↗
• MalfunctionJun 12, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE CAP DOESN'T STAY ON GAS SYRINGE. THERE WAS PATIENT INVOLVEMENT AND THERE WAS NO HUMAN HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19518738 ↗
• MalfunctionMay 14, 2024Separation Problem; Separation Problem

  IT WAS REPORTED THAT THE CAP DOESN'T STAY ON GAS SYRINGE. THERE WAS NO PATIENT INVOLVEMENT AND THERE WAS NO HUMAN HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19311187 ↗
• MalfunctionMay 14, 2024Separation Problem; Separation Problem

  IT WAS REPORTED THAT THE NURSE NOTICED SEVERAL SYRINGES THE LIDS DOES NOT STAY ON. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND THERE WAS NO HUMAN HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19311129 ↗
• MalfunctionMay 14, 2024Separation Problem; Separation Problem

  IT WAS REPORTED THAT THE CAP DOESN'T STAY ON GAS SYRINGE. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND THERE WAS NO HUMAN HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19311026 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K952516. One submission often covers many models, so check the product and lot details in each record.

• Z-1100-2026 · Dec 19, 2025 · Open, Classified
  Pulsator Arterial Blood Sampling Kit, Item Numbers 4044EG-1 4080P-2 4084P-1 4080PE 4080PG
• Z-0141-2024 · Sep 6, 2023 · Open, Classified
  Portex Pro-Vent Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes, REF 4599P-1
• Z-1715-2020 · Jan 7, 2020 · Terminated
  Portex LineDraw Arterial Blood Sampling Syringe with Dry Lithium Heparin for Gases and Electrolytes
• Z-1716-2020 · Jan 7, 2020 · Terminated
  Portex ProVent Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes
• Z-0842-2019 · Jun 22, 2018 · Terminated
  Aplicare Povidone Iodine Prep Pads packaged within Portex Pro-Vent Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes, models 4589P-1, 4591EG-1, 4591P-
• Z-0843-2019 · Jun 22, 2018 · Terminated
  Aplicare Povidone Iodine Prep Pads packaged within Portex Pulsator Arterial Blood Sampling Kit with Liquid Sodium Heparin, models 4037NP-1, 4039-1, 4039EG-1, 4044EG-1, 4044P-1, 405
• Z-1028-2015 · Dec 17, 2014 · Terminated
  Portex Anaerobic Pulsator Arterial Blood Sampling Kit, with Liquid Sodium Heparin for Gases and Electrolytes. Reorder Number: G1392 Product Usage: The Arterial Blood Sampling
• Z-1186-2014 · Nov 22, 2013 · Terminated
  4042E: 3 mL Line Draw, Luer lock syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro device (for sale in Europe only) Arterial Blood Sampling Line Draw Syringes are
• Z-1183-2014 · Nov 22, 2013 · Terminated
  4043G-2: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro device and ice bag Arterial Blood Sampling Line Draw Syringes are sterile, si
• Z-1188-2014 · Nov 22, 2013 · Terminated
  G1469J: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro device (for sale in Japan only) Arterial Blood Sampling Line Draw Syringes are
• Z-1187-2014 · Nov 22, 2013 · Terminated
  4043E: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro device (for sale in Europe only) Arterial Blood Sampling Line Draw Syringes are
• Z-1182-2014 · Nov 22, 2013 · Terminated
  4043-2: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro device Arterial Blood Sampling Line Draw Syringes are sterile, single-use devi
• Z-1184-2014 · Nov 22, 2013 · Terminated
  4043W-2: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro device, syringe tip cap and 6 mL Luer slip syringe Arterial Blood Sampling Li
• Z-1190-2014 · Nov 22, 2013 · Terminated
  G1762: 3 mL Line Draw, Luer lock syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro device, syringe tip cap, and 5 mL Luer lock syringe Arterial Blood Sampling Line
• Z-1180-2014 · Nov 22, 2013 · Terminated
  4040-2: Umbilical 3 mL Line Draw, Luer lock syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro device, 22g x 1 needle, and Point-Lok needle safety device Arterial B

…and 16 more.