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Recall Observatory FDA recall evidence

Device product

Medline Sterile 3mL Syringes with 21GA x 1 Inch Needle 80 each REF DYND3ML21G1A lot 18JBH655 (01) 1088438982153.

Z-1546-2020

February 10, 2020

Class II

Product summary

Firm
Medline Industries Inc
Event
Event 85022
Status
Terminated
Classification
Class II
Quantity
3,690 units
Official record key
device-enforcement:Z-1546-2020

Official wording

Reason: Voids were discovered in the packaging seal and loss of sterility on the outside of the contents within the Tyvek Form-Fill-Seal packaging.

Code information: REF DYND3ML21G1A lot 18JBH655 (01) 1088438982153

Distribution pattern: US Nationwide: MA, LA, IL, MO, MI, MN, NJ, KS, GA, NY, PA, SD, CT, TN, MD, OH, VA, FL, TX, KY, CO, IN, AL, CA, MT, OR, AK, AL, DC, IA, ME, NV, NE, SC, WV, WY, RI, NC, AZ, UT, DE and WI.

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    loss of sterility