Device product
Medline Sterile 3mL Syringes with 21GA x 1 Inch Needle 80 each REF DYND3ML21G1A lot 18JBH655 (01) 1088438982153.
Z-1546-2020
Product summary
- 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
loss of sterility