Modification to: Monojet Prefill 0.9% Sodium Chloride Flush Syringe, Monojet Prefill Heprin Lock Flush Syringe

• • Ongoing Z-0119-2022 FDA Class I ·initiated 19 Aug 2021

  Monoject 0.9% Sodium Chloride Flush Syringe Manufactured by Cardinal Health and placed into kits. Potential for the plunger to draw back after air has been expelled and reintroduce air back into the syringe.

• 3 recalls, same reason

  • Ongoing Z-2284-2021 FDA Class I ·initiated 4 Aug 2021
  • Ongoing Z-2285-2021 FDA Class I ·initiated 4 Aug 2021
  • Ongoing Z-2286-2021 FDA Class I ·initiated 4 Aug 2021

  Potential for the plunger to draw back after the air has been expelled and reintroduce air back into the syringe.

• 9 recalls, same reason

  • Terminated Z-2182-2013 FDA Class II ·initiated 16 Aug 2013
  • Terminated Z-2183-2013 FDA Class II ·initiated 16 Aug 2013
  • Terminated Z-2185-2013 FDA Class II ·initiated 16 Aug 2013
  • Terminated Z-2179-2013 FDA Class II ·initiated 16 Aug 2013
  • Terminated Z-2181-2013 FDA Class II ·initiated 16 Aug 2013
  • Terminated Z-2178-2013 FDA Class II ·initiated 16 Aug 2013
  • Terminated Z-2180-2013 FDA Class II ·initiated 16 Aug 2013
  • Terminated Z-2186-2013 FDA Class II ·initiated 16 Aug 2013
  • Terminated Z-2184-2013 FDA Class II ·initiated 16 Aug 2013

  Monoject prefill flush syringes may contain non-sterile water and labeled as saline or heparin

• 6 recalls, same reason

  • Terminated Z-0568-2011 FDA Unclassified (pre-2012) ·initiated 15 Nov 2010
  • Terminated Z-0567-2011 FDA Unclassified (pre-2012) ·initiated 15 Nov 2010
  • Terminated Z-0566-2011 FDA Unclassified (pre-2012) ·initiated 15 Nov 2010
  • Terminated Z-0569-2011 FDA Unclassified (pre-2012) ·initiated 15 Nov 2010
  • Terminated Z-0564-2011 FDA Unclassified (pre-2012) ·initiated 15 Nov 2010
  • Terminated Z-0565-2011 FDA Unclassified (pre-2012) ·initiated 15 Nov 2010

  The heparin sodium USP used to manufacture was produced with crude heparin containing Over-Sulfated Chondroitin Sulfate.

• 6 recalls, same reason

  • Terminated Z-1600-2008 FDA Unclassified (pre-2012) ·initiated 28 Mar 2008 ·on shared 510(k) K032438
  • Terminated Z-1598-2008 FDA Unclassified (pre-2012) ·initiated 28 Mar 2008 ·on shared 510(k) K032438
  • Terminated Z-1602-2008 FDA Unclassified (pre-2012) ·initiated 28 Mar 2008 ·on shared 510(k) K032438
  • Terminated Z-1595-2008 FDA Unclassified (pre-2012) ·initiated 28 Mar 2008 ·on shared 510(k) K032438
  • Terminated Z-1599-2008 FDA Unclassified (pre-2012) ·initiated 28 Mar 2008 ·on shared 510(k) K032438
  • Terminated Z-1596-2008 FDA Unclassified (pre-2012) ·initiated 28 Mar 2008 ·on shared 510(k) K032438

  Scientific Protein Laboratories (SPL), disclosed that two lots of Heparin Sodium, USP Active Pharmaceutical Ingredient has a heparin-like contaminant

• • Terminated Z-1597-2008 FDA Unclassified (pre-2012) ·initiated 28 Mar 2008 ·on shared 510(k) K032438

  Scientific Protein Laboratories (SPL), disclosed that two lots of Heparin Sodium, USP Active Pharmaceutical Ingredient has a heparin-like contaminant Tyco Healthcare, Mansfield, MA 02048

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

510(k) Number

K032438 ↗

FDA Product Code

NGT

Device Class

Class II

Regulation

21 CFR Part 880.5200

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Kendall Antimicrobial Drain Dressing for Otc Use, Model 6662

  Unclassified

  FDA 510(k) K070685 Active Cleared 14 Sep 2007

• Dover Rob-Nel Catheter

  Class II

  FDA 510(k) K040897 Active Cleared 20 Jul 2004

• Kendall Scd Express Kambia Thigh Length Tearaway Sleeve

  Class II

  FDA 510(k) K040649 Active Cleared 15 Jul 2004

• Monoject Prefill Heparin Lock Flush Syringe

  Class II

  FDA 510(k) K013556 Active Cleared 31 Dec 2001

• Kendall Lifetrace Umbilical Blood Collection Kit, Code 56501

  Class II

  FDA 510(k) K032827 Active Cleared 8 Dec 2003

• Dover 100% Silicone Foley Catheter with Temperature Sensor

  Class II

  FDA 510(k) K071049 Active Cleared 16 Oct 2007

See all devices from Tyco Healthcare →