Terminated

Heparin I.V. Flush Syringe is available is pre-filled polypropylene syringes, 100 units/mL, 3 mL fill in a 12 mL syringe.

FDA Recall Z-1149-2014 · Posted 2014-03-06

Recalling FirmMedefil Incorporated

Recall StatusTerminated

Product CodeNZW

Date Initiated2014-02-19

Date Terminated2017-09-05

Product Quantity1,608 Master Cartons

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).

Firm 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.

Root Cause

Labeling Change Control

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K092491MEDEFIL'S HEPARIN I.V. FLUSH SYRINGE 1 UNIT/ML; 10 UNITS/ML; AND 100 UNITS/ML IN VARIOUS FILL SIZESMedefil, Inc. · 2010-02-03

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.