Z-1612-2023 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- May 24, 2023
- Initiation Date
- April 14, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 50 units
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.
Distribution Pattern
US: WA OUS: None
Code Information
Lot # 0000157564, UDI-DI: 00885825013585