Sterile Field Saline and Heparin Lock Flush Syringes

• • Terminated Z-0973-2009 FDA Unclassified (pre-2012) ·initiated 13 Jan 2009 ·on shared 510(k) K053120

  Sterility Issue: There is the possibility that the affected lots have pouches that were not sealed properly and could potentially compromise the external sterility of the syringes.

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

510(k) Number

K053120 ↗

FDA Product Code

FOZ

Device Class

Class II

Regulation

21 CFR Part 880.5200

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Microbore Extension Set

  Class II

  FDA 510(k) K942349 Active Cleared 8 Feb 1995

• 0.9% Sodium Chloride Injection, USP - 2.5 mL in 3 mL Syringe, 0.9% Sodium Chloride Injection, USP-3mL in 10 mL Syringe, 0.9% Sodium Chloride Injection, USP - 5 mL in 10 mL Syringe, 0.9% Sodium Chloride Injection, USP - 10 mL in 10 mL Syringe

  Class II

  FDA 510(k) K142620 Active Cleared 12 Dec 2014

• Swabcap

  Class II

  FDA 510(k) K083508 Active Cleared 28 Apr 2009

• Syrex Heparin Lock Flush Syringe, 1 Unit/Ml & 2 Units/Ml

  Class II

  FDA 510(k) K061497 Active Cleared 23 Feb 2007

• Syrex Pre-Filled Syringe

  Class II

  FDA 510(k) K023740 Active Cleared 13 May 2003

• Excelsior Disposable Syringe W/Normal Saline (.9% Sodium Chloride)

  Class II

  FDA 510(k) K962938 Active Cleared 25 Oct 1996

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