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Recall Observatory FDA recall evidence

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.

Z-1295-2024

January 23, 2024

Class II

Product summary

Firm
MEDLINE INDUSTRIES, LP - Northfield
Event
Event 94036
Status
Ongoing
Classification
Class II
Quantity
37,368 boxes
Official record key
device-enforcement:Z-1295-2024

Official wording

Reason: Product failed sterility testing.

Code information: Lot numbers 10322040003, 10322050003, 10322070006, and 10322100002; UDI-DI 0500428645208.

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Product failed sterility testing.