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Recall Observatory FDA recall evidence

Device product

Monoject Hypodermic Safety Needle 25G x 5/8" Item Code 1182558 - 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-1455-2020

January 15, 2020

Class II

Product summary

Firm
Cardinal Health 200, LLC
Event
Event 84779
Status
Terminated
Classification
Class II
Quantity
Unavailable
Official record key
device-enforcement:Z-1455-2020

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. 15063004, Item Code 1182558, Expires 5/31/2020

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

    reason.sterility_assurance · v1.0.0

    Non-sterile product was shipped to customers. Product package is labeled as both "STERILE