Vaclok Syringe

• • Terminated Z-0202-2022 FDA Class II ·initiated 20 Oct 2021

  Syringe Kits labeled for distribution OUS were inadvertently shipped to US customers.

• 4 recalls, same reason

  • Terminated Z-0505-2011 FDA Unclassified (pre-2012) ·initiated 22 Oct 2010
  • Terminated Z-0506-2011 FDA Unclassified (pre-2012) ·initiated 22 Oct 2010
  • Terminated Z-0503-2011 FDA Unclassified (pre-2012) ·initiated 22 Oct 2010
  • Terminated Z-0504-2011 FDA Unclassified (pre-2012) ·initiated 22 Oct 2010

  Packaging for syringes may have holes which would compromise the sterility of the package contents.

• 5 recalls, same reason

  • Terminated Z-0308-04 FDA Unclassified (pre-2012) ·initiated 2 Oct 2003 ·on shared 510(k) K994253
  • Terminated Z-0309-04 FDA Unclassified (pre-2012) ·initiated 2 Oct 2003 ·on shared 510(k) K994253
  • Terminated Z-0311-04 FDA Unclassified (pre-2012) ·initiated 2 Oct 2003 ·on shared 510(k) K994253
  • Terminated Z-0307-04 FDA Unclassified (pre-2012) ·initiated 2 Oct 2003 ·on shared 510(k) K994253
  • Terminated Z-0310-04 FDA Unclassified (pre-2012) ·initiated 2 Oct 2003 ·on shared 510(k) K994253

  Damaged hemostasis valves that prevent or present difficulty when inserting catheters.

• • Terminated Z-0139-04 FDA Unclassified (pre-2012) ·initiated 1 Oct 2003

  There is a potential for the PETG blister trays to bond together with varying degrees of attachment. The potential for non-sterility exists when the attached trays are seperated by force and holes or cracks are generated in the seperated trays.

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

1. 2 Oct 2003 Recall initiated FDA recalls Z-0308-04
2. 2 Oct 2003 Recall initiated FDA recalls Z-0309-04
3. 2 Oct 2003 Recall initiated FDA recalls Z-0311-04
4. 2 Oct 2003 Recall initiated FDA recalls Z-0307-04
5. 2 Oct 2003 Recall initiated FDA recalls Z-0310-04
6. 22 Oct 2010 Recall initiated FDA recalls Z-0505-2011
7. 22 Oct 2010 Recall initiated FDA recalls Z-0506-2011
8. 22 Oct 2010 Recall initiated FDA recalls Z-0503-2011
9. 22 Oct 2010 Recall initiated FDA recalls Z-0504-2011
10. 20 Oct 2021 Recall initiated FDA recalls Z-0202-2022

2 earlier events are in the sections above.

510(k) Number

K994253 ↗

FDA product code

FMF

Device class

Class II

Regulation

21 CFR Part 880.5860

Advisory committee

General Hospital

FDA decision

SESE Substantially Equivalent

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Source: 510k-lineage (choiben314), CC BY 4.0

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Other devices filed under FDA product code FMF (Syringe, Piston).

• Genesis Spray Tip Atomizer by Mai
• Yi Xin Sterile Syringe for Single Use by Jiangxi Sanxin (Eversincere) Medical Devices Group
• Allergist Syringes by Abco Dealers, Inc.
• MicroDose Injector by MedOne Surgical, Inc.
• Ideas' Port by Ideal Medical, Inc.
• Casandra Syringe Cap by Casandra Medical Corp.
• Acacia Piston Syringe by Acacia, Inc.
• 10CC Control Syringe by Medi-Plast Intl., Inc.
• Patient Safe Luer Cap by Retractable Technologies, Inc.
• Duoflo Dispenser by Hemaedics, Inc.

• Prelude Roadster™

  Class II

  GUDID on market

• Merit Medical® Initial Release

  Class II

  GUDID on market

• ReSolve® G

  Class II

  GUDID on market

• Prelude® F

  Class II

  GUDID on market

See all devices from Merit Medical Systems, Inc. →