Infa-Therm Transport Mattress recall: Labeling Error
Infa-Therm Transport Mattress, Reference Number 989805616831 1015
Why was Infa-Therm Transport Mattress recalled?
After the device was cleared by the FDA, Philips made changes to the labeling that do not fall within the existing FDA clearance. These devices with the modified labeling cannot be distributed or sold without new 510(k) clearance.
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?
All units are impacted
- Product
- Infa-Therm Transport Mattress, Reference Number 989805616831 1015
- Recalling firm
- Philips North America Llc
- Quantity
- 141,744 units (Updated to 141,750 units as of 2/15/22)
- Distribution
- US Nationwide and Canada
- Recall date
- January 26, 2022
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)