510(k) K092491 ยท NZW Heparin, Vascular Access Flush
MEDEFIL'S HEPARIN I.V. FLUSH SYRINGE 1 UNIT/ML; 10 UNITS/ML; AND 100 UNITS/ML IN VARIOUS FILL SIZES
| Applicant | Medefil, Inc., Glendale Heights IL, US |
| Decision | Substantially Equivalent, Feb 3, 2010 |
| Received | Aug 13, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K092491
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 6, 2014 | Medefil Incorporated Heparin I.V. Flush Syringe is available is pre-filled polypropylene syringes, 100 units/mL, 3 mL fill in a 12 mL syringe. Terminated |
NZW | None listed |
| Dec 10, 2010 | Medefil Incorporated Medefil Heparin I.V. Flush Syringe 100 units/mL; a polypropylene luer locking syringe containing Heparin Lock Flush Solution, USP, a sterile non-pyrogenic, isotonic injection; each mL in a Heparin I.V Terminated |
NZW | None listed |
| Dec 10, 2010 | Medefil Incorporated Medefil Heparin I.V. Flush Syringe 10 units/mL; a polypropylene luer locking syringe containing Heparin Lock Flush Solution, USP, a sterile non-pyrogenic, isotonic injection; each mL in a Heparin I.V. Terminated |
NZW | None listed |
| Dec 10, 2010 | Medefil Incorporated Medefil Heparin I.V. Flush Syringe 1 units/mL; a polypropylene luer locking syringe containing Heparin Lock Flush Solution, USP, a sterile non-pyrogenic, isotonic injection; each mL in a Heparin I.V. Terminated |
NZW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.