FDA-Device2023-05-24Class II

REF 5065, Kendall, Impad Rigid Sole Foot Cover, Regular Pair ,<12", Rx Only Non-Sterile

Stryker Sustainability Solutions
Hazard

Through complaint surveillance, it was identified that reprocessed Deep vein thrombosis (DVT) Compression Sleeves may be mislabeled and/or mispackaged.

Sold states
US: WA OUS: None
Affected count
50 units
Manufactured in
1810 W Drake Dr, N/A, Tempe, AZ, United States
Products
REF 5065, Kendall, Impad Rigid Sole Foot Cover, Regular Pair ,<12", Rx Only Non-Sterile

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1612-2023

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