FDA recall Z-1295-2024

MEDLINE INDUSTRIES, LP - Northfield · Class II · device

Product

CVS Health Waterproof Wound Tracking Dressing, REF CVS690330, immediate package contains 1 sterile dressing, 4 in. x 4 in., 4 dressings per box, 24 boxes per case.

Reason for recall

Product failed sterility testing.

Distribution

US Nationwide distribution in the states of AL, CA, FL, IN, MI, MO, NJ, NY, PA, RI, SC, TN, TX. and VA. There was no foreign/government/military distribution.

Key facts

Status
Ongoing
Initiation date
2024-01-23
Report date
2024-03-20
Voluntary/Mandated
Voluntary: Firm initiated
Location
Northfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1295-2024