Heparin I.V. Flush Syringe is available is pre-filled polypropylene syringes, 100 units/mL, 3 mL fill in a 12 mL syringe
FDA device recall Z-1149-2014 · posted 2014-03-06 · Terminated
Recall details
- Recalling firm
- Medefil Incorporated
- 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).
- Action taken
- 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
- Status
- Terminated
- Product code
- NZW
- Quantity affected
- 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.
- Date initiated
- 2014-02-19
- Date posted
- 2014-03-06
- Date terminated
- 2017-09-05
- Location
- Glendale Heights, IL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MEDEFIL'S HEPARIN I.V. FLUSH SYRINGE 1 UNIT/ML; 10 UNITS/ML; AND 100 UNITS/ML IN VARIOUS FILL SIZES (K092491) | Medefil, Inc. | 2010-02-03 |