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U.S. Department of Health and Human Services

Class 3 Device Recall Heparin I.V. Flush Syringe

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  Class 3 Device Recall Heparin I.V. Flush Syringe see related information
Date Initiated by Firm February 19, 2014
Date Posted March 06, 2014
Recall Status1 Terminated 3 on September 05, 2017
Recall Number Z-1149-2014
Recall Event ID 67562
510(K)Number K092491  
Product Classification Heparin, vascular access flush - Product Code NZW
Product Heparin I.V. Flush Syringe is available is pre-filled polypropylene syringes, 100 units/mL, 3 mL fill in a 12 mL syringe.
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.
Recalling Firm/
Manufacturer		 Medefil Incorporated
250 Windy Point Dr
Glendale Heights IL 60139-3805
For Additional Information Contact Mr. Edwin E. Rodriguez
630-682-4600
Manufacturer 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).
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = NZW and Original Applicant = MEDEFIL, INC.
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