Z-1149-2014Class III

Heparin I.V. Flush Syringe is available is pre-filled polypropylene syringes, 100 units/mL, 3 mL fill in a 12...

Name: Z-1149-2014 Heparin I.V. Flush Syringe is available is pre-filled polypropylene syringes, 100 units/mL, 3 mL fill in a 12...
Creator: Medefil Incorporated
Published: 2014-02-19
License: https://open.fda.gov/license/

Medefil, Inc. / initiated 2014-02-19 / Terminated / root cause: labeling and UDI

FDA source

Medefil Incorporated began a recall of Heparin I.V. Flush Syringe is available is pre-filled polypropylene syringes, 100 units/mL, 3 mL fill in a 12 mL syringe on 2014-02-19. FDA classified it as Class III and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1149-2014
Classification: Class III
Status: Terminated
Initiated: 2014-02-19
Posted: 2014-03-06
Terminated: 2017-09-05
Recalling firm: Medefil, Inc.
Product: Heparin I.V. Flush Syringe is available is pre-filled polypropylene syringes, 100 units/mL, 3 mL fill in a 12 mL syringe.
Product code: NZW Heparin, Vascular Access Flush
Reason for recall: 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).
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: 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.
Quantity in commerce: 1,608 Master Cartons
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 codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1149-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1149-2014	Class III	Terminated	Voluntary: Firm initiated	2014-03-12	2014-03-06

Product code NZW

K092491Class IIMedefil's Heparin i.v. Flush Syringe 1 Unit/ml; 10 Units/ml; and 100 Units/ml in Various Fill SizesMedefil, Inc. / cleared 2010-02-03

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)