Z-1149-2014 Class III Terminated
FDA device recall Z-1149-2014 was initiated by Medefil Incorporated on February 19, 2014 and is designated Class III. 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… The recall status is terminated (terminated September 5, 2017). Affected quantity: 1,608 Master Cartons.
Recall Details
- Product Type
- Devices
- Report Date
- March 12, 2014
- Initiation Date
- February 19, 2014
- Termination Date
- September 5, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,608 Master Cartons
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.
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).
Distribution Pattern
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.
Code Information
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.