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

510(k) K061497

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

13 closed

Documents

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 10 Oct 2026. What this means

Regulatory status

as of registry sync 10 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK061497	Date23 Feb 2007Cleared	StatusActive

13 recalls · FDA

12 recalls, same reason
- Terminated Z-1802-2012 FDA Class II initiated 11 May 2012
- Terminated Z-1798-2012 FDA Class II initiated 11 May 2012
- Terminated Z-1799-2012 FDA Class II initiated 11 May 2012
- Terminated Z-1797-2012 FDA Class II initiated 11 May 2012
- Terminated Z-1807-2012 FDA Class II initiated 11 May 2012
- Terminated Z-1801-2012 FDA Class II initiated 11 May 2012
- Terminated Z-1803-2012 FDA Class II initiated 11 May 2012
- Terminated Z-1808-2012 FDA Class II initiated 11 May 2012
- Terminated Z-1806-2012 FDA Class II initiated 11 May 2012
- Terminated Z-1805-2012 FDA Class II initiated 11 May 2012
- Terminated Z-1800-2012 FDA Class II initiated 11 May 2012
- Terminated Z-1804-2012 FDA Class II initiated 11 May 2012
Manufacturer issued a voluntary recall on multiple lots of VY(TM)Flush Heparin Lock Flush Syringes therefore Vygon has subsequently initiated a recall on Vygon branded Heparin Lock Flush Syringes and kits containing the syringes.
- Terminated Z-1707-2012 FDA Not yet classified initiated 7 May 2012
Some lots of Heparin Lock Flush, USP Syringes (3 mL fill in 10 ml syringe, 4 mL fill in 10 ml syringe, 5 mL fill in 10 ml and 6 ml in 10 ml syringe), failed Anti-Factor IIa assay for potency.

1 jurisdiction

United States — FDA 510(k) Active

510(k)