Invirostripe Luer Lock Syringes (1, 3, 10, 20, 30 and 60 Ml)

• • Terminated Z-1453-2020 FDA Class II ·initiated 15 Jan 2020 ·on shared 510(k) K101359

  Non-sterile product was shipped to customers. Product package is labeled as both "STERILE" and "NON-STERILR" ; the product did not undergo sterilization process and is non-sterile. The usage of a needle that is not sterile could result in infection. Firm is not aware of any reports of patient harm.

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

510(k) Number

K101359 ↗

FDA Product Code

FMF

Device Class

Class II

Regulation

21 CFR Part 880.5860

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

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  Class II

  FDA 510(k) K070203 Active Cleared 23 Apr 2007

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  Class II

  FDA 510(k) K092413 Active Cleared 4 Sep 2009

• 1 Ml Fixed Needle, 3 Ml Luer Lock, 5 Ml Luer Lock, 10 Ml Luer Lock, 20 Ml Luerl Lock Safety Syringes

  Class II

  FDA 510(k) K092430 Active Cleared 4 Sep 2009

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  Class II

  FDA 510(k) K083851 Active Cleared 15 May 2009

• Invirolink and Inviro Tip Blunt Cannulas, Model 130001, 130501, 140001, 140002, 140003

  Class II

  FDA 510(k) K071307 Active Cleared 12 Feb 2008

• Invirostripe 3ml, 5ml, 10ml Luer Lock Syringes

  Class II

  FDA 510(k) K081436 Active Cleared 22 Oct 2008