Device product
Monoject 3mL Syringe with Hypodermic Safety Needle, 22G x 1-1/2 . Item Code 11832215 - 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.
Z-1453-2020
Product summary
- Event
- Event 84779
- Status
- Terminated
- Classification
- Class II
- Quantity
- 8400 each
- Official record key
device-enforcement:Z-1453-2020
Official wording
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.
Code information: Lot No. 15072015, Item Code 11832215 , Expires 06/20/2020.
Distribution pattern: 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, South Africa, Belgium, Germany, Ireland, Portugal Spain, and UK.
Derived failure modes
-
Sterility assurance
Non-sterile product was shipped to customers. Product package is labeled as both "STERILE