PlainRecalls
FDA Devices Moderate Class II Ongoing

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

Reported: May 24, 2023 Initiated: April 14, 2023 #Z-1612-2023

Product Description

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

Reason for Recall

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

Details

Units Affected
50 units
Distribution
US: WA OUS: None
Location
Tempe, AZ

Frequently Asked Questions

What product was recalled?
REF 5065, Kendall, Impad Rigid Sole Foot Cover, Regular Pair ,<12", Rx Only Non-Sterile. Recalled by Stryker Sustainability Solutions. Units affected: 50 units.
Why was this product recalled?
Through complaint surveillance, it was identified that reprocessed Deep vein thrombosis (DVT) Compression Sleeves may be mislabeled and/or mispackaged.
Which agency issued this recall?
This recall was issued by the FDA Devices on May 24, 2023. Severity: Moderate. Recall number: Z-1612-2023.