FDA recall Z-1544-2020

Medline Industries Inc · Class II · device

Product

Medline Stick Sponge Presaturated W/PVP REF DYND70288 DYND70288H 2/PK Expiration 06/30/2022.

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

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.

Key facts

Status
Terminated
Initiation date
2020-02-10
Report date
2020-04-01
Termination date
2023-02-13
Voluntary/Mandated
Voluntary: Firm initiated
Location
Northfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1544-2020