—#190673

Product

Heel Snuggler, Reference # 989805603411 99047

FDA product code: MPO — Infant Heel Warmer (Chemical Heat Pack)
Device class: Class 1
Medical specialty: Physical Medicine
510(k) numbers: K040044
Affected lot / code info: All units are impacted

Why it was 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.

Root cause (FDA determination)

No Marketing Application

Action the firm took

URGENT Medical Device Recall notification letters dated November 2021 were sent to customers. The actions that should be taken by the customer / user to prevent risks to patients or users 1. Identify all Infant Heel Warmers and Heel Snugglers in your possession. 2. Destroy all Infant Heel Warmers and Heel Snugglers, regardless if they are expired or not. 3. Please complete the Urgent Medical Device Recall Response Form online by using the URL provided on the form. 4. Identify and source an alternative device to meet your needs. Philips will no longer offer the Infant Heel Warmers and Heel Snugglers. 5. Share this communication with your staff and other impacted departments and organizations. If you need any further information concerning this issue, please email HeelWarmers@Philips.com (preferred communication path} or contact+ 1-629-215-7280 Monday through Friday, 8AM - 3PM Central Standard Time. If you email Hee1Warmers@Philips.com, you will receive an email response with the link to submit your Recall Acknowledgement form online, as well as a response to your inquiry.

Recalling firm

Firm: Philips North America Llc
Address: 222 Jacobs St, Cambridge, Massachusetts 02141-2289

Distribution

Distribution pattern: US Nationwide and Canada.

Timeline

Recall initiated: 2021-11-29
Posted by FDA: 2022-01-19
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #190673. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.