Pro-Vent, Line Draw, Pulsator

• • 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

510(k) Number

K952516 ↗

FDA Product Code

JKA

Device Class

Class II

Regulation

21 CFR Part 862.1675

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Percutaneous Tracheostomy Kit

  Class II

  FDA 510(k) K936133 Active Cleared 23 Mar 1994

• Pro-Vent(Tm), Pulsator(R), and Line Draw(Tm) Arterial Blood Sampling Syringes

  Class II

  FDA 510(k) K945777 Active Cleared 22 Dec 1994

• Sims Cpap System

  Class II

  FDA 510(k) K953485 Active Cleared 26 Oct 1995

• Regional Anesthesia Trays Open recall

  Class II

  FDA 510(k) K965017 Active Cleared 14 Mar 1997

• Fenestrated Flexible D.I.C. Tracheostomy Tube Cuffed

  Class II

  FDA 510(k) K972385 Active Cleared 20 Jan 1998

• Wallace IV Cannula

  Class II

  FDA 510(k) K932946 Active Cleared 1 Sep 1995

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