Heel Snuggler, Reference # 989805603411 99047

FDA device recall Z-0507-2022 · posted 2022-01-19 · Open, Classified

Recall details

Recalling firm

Philips North America Llc

Reason for recall

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.

Action taken

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.

Root cause

No Marketing Application

Status

Open, Classified

Product code

MPO

Quantity affected

2,509,100 units (Updated to 2,515,200 as of 2/15/22)

Distribution

US Nationwide and Canada.

Date initiated

2021-11-29

Date posted

2022-01-19

Location

Cambridge, MA

Related 510(k) clearances