Z-1546-2020 Class II Terminated
FDA device recall Z-1546-2020 was initiated by Medline Industries Inc on February 10, 2020 and is designated Class II. Reason for recall: Voids were discovered in the packaging seal and loss of sterility on the outside of the contents within the Tyvek Form-Fill-Seal packaging. The recall status is terminated (terminated February 13, 2023). Affected quantity: 3,690 units.
Recall Details
- Product Type
- Devices
- Report Date
- April 1, 2020
- Initiation Date
- February 10, 2020
- Termination Date
- February 13, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3,690 units
Product Description
Medline Sterile 3mL Syringes with 21GA x 1 Inch Needle 80 each REF DYND3ML21G1A lot 18JBH655 (01) 1088438982153.
Reason for Recall
Voids were discovered in the packaging seal and loss of sterility on the outside of the contents within the Tyvek Form-Fill-Seal packaging.
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.
Code Information
REF DYND3ML21G1A lot 18JBH655 (01) 1088438982153