Heparin I.V. Flush Syringe is available is pre-filled… recallZ-1149-2014 · Medefil Incorporated · initiated Feb 19, 2014
Class III Terminated All recalls posted in March 2014
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Medefil Incorporated or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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 this product is actually Product No. MIH-3333 (Heparin I.V. Flush Syringe 100 units/mL; 3 mL fill in 12 mL Syringe).
FDA root cause category: Labeling Change Control
What the company is doing
URGENT MEDICAL DEVICE CORRECTION letters dated February 19, 2014 were sent to all direct accounts. The letters included instructions to: quarantine the recalled products; and,complete and return the attached customer response form (via Fax to 630-681-9100 or via mail to Medefil Inc., 250 Windy Point Drive, Glendale Heights, IL 60139) so that the correct number of replacement labels can be sent from Medefil.
Recall details
- Recall number
- Z-1149-2014
- Recall class
- Class III
- Status
- Terminated
- Initiated by the company
- Feb 19, 2014
- Posted by the FDA
- Mar 6, 2014
- Recalling firm
- Medefil Incorporated
- Quantity
- 1,608 Master Cartons
- Product code
- NZW
- FDA submissions
- K092491
- Distribution
- USA (nationwide) including the states of AZ, CA, CO, FL, GA, IL, LA, MA, MD, MI, MN, MO, MS, NC, NJ, NY, OH, OK, PA, SC, TX, UT, and WI, and the country of Canada.
Product description
Heparin I.V. Flush Syringe is available is pre-filled polypropylene syringes, 100 units/mL, 3 mL fill in a 12 mL syringe.
Code information (models, lots, serial numbers)
Product Number: MIH-3333; NDC Number: 64253-333-33; Lot Numbers and Expiration Dates: Lot H114120N, Expires 12/15; Lot H113403N, Expires 11/15; Lot H113369N, Expires 10/15; Lot H113327N, Expires 8/15; Lot H113291N, Expires 7/15; Lot H113266N, Expires 6/15; Lot H113232N, Expires 5/15; Lot H113185N, Expires 3/15.
Other devices under the same FDA submission
3 devices cleared under K092491 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Heparin Lock Flush Syringe 10 Units/mL 3mL in 12mL syringeMedefil, Inc. · Heparin, Vascular Access Flush1 report
- Heparin Lock Flush Syringe 100 Unit/mL 3mL in 6mL syringeMedefil, Inc. · Heparin, Vascular Access Flush1 report
- Heparin Lock Flush Syringe 1 unit/mL 2 mL in 6mL SyringeMedefil, Inc. · Heparin, Vascular Access Flush1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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