Portex 4598P-2

• FDA 510(k) K952516 decided 14 Jul 1995 Active
• FDA GUDID UDI-DI 20351688040333 listed 9 Jan 2017 Listed

• • Ongoing Z-1100-2026 FDA Class II ·initiated 19 Dec 2025

  Affected lots of syringes may have a crack on the syringe collar, which may lead to delayed or repeated blood draw/fluid delivery. This issue may also lead to blood leakage during sampling of arterial blood or leakage during fluid delivery.

• • Ongoing Z-0141-2024 FDA Class II ·initiated 6 Sep 2023

  The complaint involved the absence of a component called "ASM Filter-Pro ABG SYR CAP" from the packaging of Pro-Vent Arterial Blood Sampling (ABG) Kits. Specifically, this issue affected a total of 31,900 kits under the FGSKU# 4599P-1 and Lot# 4331283. Tubes without caps have the potential to generate delayed or erroneous test results and/or exposure to infectious blood.

• • Terminated Z-1716-2020 FDA Class II ·initiated 7 Jan 2020

  Lots of Smiths Medical Portex Pro-Vent and LineDraw Arterial Blood Sampling syringes may have broken luers.

• • Terminated Z-1715-2020 FDA Class II ·initiated 7 Jan 2020

  Portex Pro-Vent and LineDraw Arterial Blood Sampling syringes may have broken luers.

• 2 recalls, same reason

  • Terminated Z-0843-2019 FDA Class II ·initiated 22 Jun 2018
  • Terminated Z-0842-2019 FDA Class II ·initiated 22 Jun 2018

  The povidone iodine prep pads packaged with the arterial blood sampling kits will not maintain the iodine potency through its labeled 36-month expiration dating.

• • Terminated Z-1028-2015 FDA Class III ·initiated 17 Dec 2014

  The outer box label is marked with the correct expiration date of 08/2016. The inner Tyvek Unit Label is marked with 08-2017 which exceeds the actual expiration date by one year.

• 13 recalls, same reason

  • Terminated Z-1183-2014 FDA Class II ·initiated 22 Nov 2013
  • Terminated Z-1191-2014 FDA Class II ·initiated 22 Nov 2013
  • Terminated Z-1189-2014 FDA Class II ·initiated 22 Nov 2013
  • Terminated Z-1182-2014 FDA Class II ·initiated 22 Nov 2013
  • Terminated Z-1185-2014 FDA Class II ·initiated 22 Nov 2013
  • Terminated Z-1180-2014 FDA Class II ·initiated 22 Nov 2013
  • Terminated Z-1192-2014 FDA Class II ·initiated 22 Nov 2013
  • Terminated Z-1187-2014 FDA Class II ·initiated 22 Nov 2013
  • Terminated Z-1186-2014 FDA Class II ·initiated 22 Nov 2013
  • Terminated Z-1184-2014 FDA Class II ·initiated 22 Nov 2013
  • Terminated Z-1181-2014 FDA Class II ·initiated 22 Nov 2013
  • Terminated Z-1190-2014 FDA Class II ·initiated 22 Nov 2013
  • Terminated Z-1188-2014 FDA Class II ·initiated 22 Nov 2013

  issue with the plunger tip of the Portex Arterial Blood Sampling Line Draw Syringes

• 11 recalls, same reason

  • Terminated Z-0253-05 FDA Unclassified (pre-2012) ·initiated 9 Sep 2004
  • Terminated Z-0247-05 FDA Unclassified (pre-2012) ·initiated 9 Sep 2004
  • Terminated Z-0249-05 FDA Unclassified (pre-2012) ·initiated 9 Sep 2004
  • Terminated Z-0248-05 FDA Unclassified (pre-2012) ·initiated 9 Sep 2004
  • Terminated Z-0250-05 FDA Unclassified (pre-2012) ·initiated 9 Sep 2004
  • Terminated Z-0254-05 FDA Unclassified (pre-2012) ·initiated 9 Sep 2004
  • Terminated Z-0252-05 FDA Unclassified (pre-2012) ·initiated 9 Sep 2004
  • Terminated Z-0251-05 FDA Unclassified (pre-2012) ·initiated 9 Sep 2004
  • Terminated Z-0227-05 FDA Unclassified (pre-2012) ·initiated 9 Sep 2004
  • Terminated Z-0244-05 FDA Unclassified (pre-2012) ·initiated 9 Sep 2004
  • Terminated Z-0246-05 FDA Unclassified (pre-2012) ·initiated 9 Sep 2004

  Sterility of the device is compromised due to packaging defects

1. 22 Nov 2013 Recall initiated FDA recalls Z-1190-2014
2. 22 Nov 2013 Recall initiated FDA recalls Z-1188-2014
3. 17 Dec 2014 Recall initiated FDA recalls Z-1028-2015
4. 9 Jan 2017 Listed FDA GUDID 20351688040333
5. 22 Jun 2018 Recall initiated FDA recalls Z-0843-2019
6. 22 Jun 2018 Recall initiated FDA recalls Z-0842-2019
7. 7 Jan 2020 Recall initiated FDA recalls Z-1716-2020
8. 7 Jan 2020 Recall initiated FDA recalls Z-1715-2020
9. 6 Sep 2023 Recall initiated FDA recalls Z-0141-2024
10. 19 Dec 2025 Recall initiated FDA recalls Z-1100-2026

23 earlier events are in the sections above.

Trade name

Portex

Generic name

Arterial blood sampling kit

Model / reference

4598P-2

Primary DI / UDI-DI

20351688040333

510(k) Number

K952516 ↗

FDA product code

JKA

GMDN term

Arterial blood sampling kit

Device class

Class II

Regulation number

862.1675

GUDID distribution status

In Commercial Distribution

Category: Arterial blood sampling kit

Other devices filed under FDA product code JKA (Tubes, vials, systems, serum separators, blood collection).

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