Reported Mar 12, 2014 · Terminated
Heparin I.V. Flush Syringe is available is pre-filled polypropylene syringes, 100 units/mL, 3 mL fill in a 12 mL…
Medefil Incorporated
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medefil Incorporated · 250 Windy Point Dr · Glendale Heights, IL · 60139-3805
Is this the product you have?
- Heparin I.V. Flush Syringe is available is pre-filled polypropylene syringes, 100 units/mL, 3 mL fill in a 12 mL syringe.
- Lot codes and dates
10 of 10 products
Products covered by this recall Model / number Product as published 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. - Amount recalled
- 1,608 Master Cartons
Where it was sold
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).
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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