Severity
Low
FDA Devices recall · Reported March 12, 2014
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 b…
Medefil Incorporated recalled Heparin I.V. Flush Syringe is available is pre-filled polypropylene syringes, 100 units/m… — a low-severity action.
Heparin I.V. Flush Syringe is available is pre-filled polypropylene syringes, 100 units/m… was recalled by Medefil Incorporated in March 12, 2014. Reason: The bar code that is printed on the Master Carton label does not correspond to the product code fully display…. Check the official notice for the remedy. Verify recall #Z-1149-2014 with the FDA Devices before acting.
The recall
Medefil Incorporated issued this low-severity FDA Devices recall — The bar code that is printed on the Master Carton label does not correspond to the product code fully display….
Sourced from official FDA Devices enforcement records. Verify recall #Z-1149-2014 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
This FDA Devices action (record #Z-1149-2014) was formally reported on March 12, 2014, with the manufacturer initiating the action on February 19, 2014. It is classified under Low severity (Class III), with a current status of Terminated. Medefil Incorporated is listed as the recalling firm, operating out of Glendale Heights, IL. Federal records list the affected scope as 1,608 Master Cartons.
The documented reason for this recall is: 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. T… Distribution data in the federal record shows the product reached: 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.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices — clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Where this recall sits in its category — 40,409 medical devices recalls on record
Of 100,165 recalls in the database, 23,668 are high severity, 72,097 moderate, and 4,400 low. This recall is classified low severity.
Counts reflect market size and reporting activity, not inherent danger — we do not rank products by risk from raw recall volume.
Severity
Low
Affected scope
1,608 Master Cartons
Related Recalls
6
6 from same agency
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 this product is actually Product No. MIH-3333 (Heparin I.V. Flush Syringe 100 units/mL; 3 mL fill in 12 mL Syringe).
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Low (Class III) |
| Status | Terminated |
| Recall number | Z-1149-2014 |
| Date reported | March 12, 2014 |
| Date initiated | February 19, 2014 |
| Recalling firm | Medefil Incorporated |
| Firm location | Glendale Heights, IL |
| Affected scope | 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. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Source: FDA, CPSC, and NHTSA federal recall databases. This recall: FDA Devices, reported March 12, 2014.
Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records — no number is typed in by an editor. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of June 2026.