Medefil Recalls Heparin Syringes Due to Incorrect Barcode Labeling
Medefil Incorporated is recalling Heparin I.V. Flush Syringes because the barcodes on the master cartons do not match the printed product codes.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which indicates the product is not likely to cause adverse health consequences. The issue is a labeling discrepancy detectable only by barcode readers, fitting the criteria for a Low severity score.
Plain-English summary
Medefil Incorporated is recalling 1,608 master cartons of Heparin I.V. Flush Syringes. The product is available in pre-filled polypropylene syringes containing 100 units/mL with a 3 mL fill in a 12 mL syringe. The recall covers specific lots with expiration dates ranging from March 2015 to December 2015.
The reason for the recall is that the barcodes printed on the master carton labels do not correspond to the product codes fully displayed on the labels. Specifically, the defective barcodes are read as Product No. MIH-3335 (5 mL fill) rather than the actual Product No. MIH-3333 (3 mL fill). This discrepancy can only be detected by using a barcode reader.
The affected product was distributed nationwide in the United States, including in Arizona, California, Colorado, Florida, Georgia, Illinois, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Texas, Utah, and Wisconsin, as well as in Canada. Consumers and healthcare facilities should stop using the affected product and contact Medefil Incorporated for instructions on return or replacement.
The recalled product
- Product
- Heparin I.V. Flush Syringe is available is pre-filled polypropylene syringes, 100 units/mL, 3 mL fill in a 12 mL syringe.
- Manufacturer
- Medefil Incorporated
- Category
- Medical Device — Syringes
- Hazard
- Affected units
- 1,608
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (18)
- 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.
Distribution
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