Recall Z-1454-2020 ยท FMI Needle, Hypodermic, Single Lumen
Cardinal Health 200, LLC
Monoject Hypodermic Safety Needle 30G X 1/2" Item Code 1183005 - Product Usage: used for general purpose injection and aspiration of fluids from vials, ampules and parts of the body below the surface of the skin.
| Date | Jan 15, 2020 |
| Status | Terminated |
| Reason | Non-sterile product was shipped to customers. Product package is labeled as both "STERILE" and "NON-STERILR" ; the product did not undergo sterilization process and is non-sterile. The usage of a needle that is not sterile could result in infection. Firm is not aware of any reports of patient harm. |
| Root cause | Under Investigation by firm |
| Action | Cardinal Health URGENT MEDICAL DEVICE RECALL EVENT #: 2019-02623 letter dated January 15, 2020. Customers were advised that this recall is being conducted of product labeled as NON-STERILR Not For Human Use (Exhibit A). Action required includes the following: 1.CHECK all storage and usage locations to confirm whether you have any units of the affected product codes and lot numbers containing the labeling outlined in Exhibit A in your possession. Exhibit A outlines examples of product labeling and how to identify the affected product. 2.SEGREGATE and QUARANTINE all on-hand product that is co |
| Quantity | 8000 |
| Distribution | Worldwide distributions - US Nationwide distributions in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, and countries of Canada, Australia, S |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K123684 | SOL-CARE SAFETY NEEDLE Sol-Millennium Medical, May 8, 2013 |