FDAClass IIMay 24, 2023

REF 5065 recall: Labeling Error

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

Why was REF 5065 recalled?

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

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot # 0000157564, UDI-DI: 00885825013585

Product
REF 5065, Kendall, Impad Rigid Sole Foot Cover, Regular Pair ,<12", Rx Only Non-Sterile
Recalling firm
Stryker Sustainability Solutions
Quantity
50 units
Distribution
US: WA OUS: None
Recall date
May 24, 2023
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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