Data / Medical devices / United States / Medefil, Inc.
Medefil, Inc.: FDA-registered device maker in Glendale Heights, IL, United States, 5 510(k) clearances
Medefil, Inc. is registered with the FDA (registration 1423982) in Glendale Heights, IL, United States. It lists 2 device types. The FDA files 5 510(k) clearances under its listings, the newest dated September 20, 2012. 3 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1423982
- FEI number
- 3001677091
- Address
- 250 Windy Point DR., Glendale Heights, IL, United States, 60139
- Owner or operator
- MEDEFIL, INC. (9036760)
- Roles
- Contract manufacturer, Manufacturer, Repackager or relabeler
- First device listed
- January 12, 2006
- Registered through
- 2026
- Brand names listed
- Heparin I. V. Flush Syringe, Normal Saline I. V. Flush Syringe, Normal Saline I. V. Flush Syringe - Sterile Field Ready
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Heparin, Vascular Access Flush | NZW | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Saline, Vascular Access Flush | NGT | 2 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 20, 2012 | K121262 | MEDEFLUSH NORMAL SALINE I.V. FLUSH SYRINGE-STERILE FIELD READY | NGT | Substantially Equivalent | Medefil, Inc. | accessdata.fda.gov |
| February 3, 2010 | K092491 | MEDEFIL'S HEPARIN I.V. FLUSH SYRINGE 1 UNIT/ML; 10 UNITS/ML; AND 100 UNITS/ML IN VARIOUS FILL SIZES | NZW | Substantially Equivalent | Medefil, Inc. | accessdata.fda.gov |
| January 28, 2010 | K091583 | MEDEFIL'S NORMAL SALINE I.V. FLUSH SYRINGE | NGT | Substantially Equivalent | Medefil, Inc. | accessdata.fda.gov |
| June 24, 2002 | K020996 | MEDEFIL'S HEPARIN I.V. FLUSH SYRINGE IN VARIOUS FILL SIZES - 1 ML FILL IN 6 ML SYRINGE LL; 2 ML FILL IN 6 ML SYRINGE LL | NGT | Substantially Equivalent | Medefil, Inc. | accessdata.fda.gov |
| June 20, 2002 | K020999 | MEDEFIL'S NORMAL SALINE FLUSH SYRINGE IN VARIOUS FILL SIZES - 1 ML FILL IN 6 ML SYRINGE LL; 2 ML FILL IN 6 ML SYRINGE LL | NGT | Substantially Equivalent | Medefil, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| February 19, 2014 | 67562 | Class III | Terminated | Heparin I.V. Flush Syringe is available is pre-filled polypropylene syringes, 100 units/mL, 3 mL fill in a 12 mL syringe. | The bar code that is printed on the Master Carton label does not correspond to the product code fully displayed on the Master Carton label. The non-matching information can only be detected by using a bar code reader. The defective bar codes will be read as Product No. MIH-3335 ( Heparin I.V. Flush Syringe 100 units/mL; 5 mL fill in 12 mL Syringe) whereas th | accessdata.fda.gov |
| November 1, 2010 | 57096 | Not yet classified | Terminated | 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. Flush Syringe cont | The heparin lock flush solution was manufactured with contaminated Heparin Sodium USP Active Pharmaceutical Ingredient (API). | accessdata.fda.gov |
| March 20, 2008 | 47378 | Not yet classified | Terminated | Medifil 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. Flush Syringe cont | The heparin lock flush solution was manufactured from contaminated Heparin Sodium USP Active Pharmaceutical Ingredient (API). The FDA has received reports of serious injuries and/or deaths in patients administered finished heparin injectable products manufactured from heparin API containing this contaminant. | accessdata.fda.gov |
Compare with other makers
Updated March 6, 2014. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.