FDA-Device2024-03-20Class II

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.

MEDLINE INDUSTRIES, LP - Northfield
Hazard

Product failed sterility testing.

Sold states
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.
Affected count
37,368 boxes
Manufactured in
3 Lakes Dr, N/A, Northfield, IL, United States
Products
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.

Official notice

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

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