Medical Device Recall: Z-0506-2022

FDA Recalls dataset · Firm: Philips North America Llc · Status: Open, Classified

Recall Action Class: N/A Date Initiated: 2021-11-29 Recall record compiled from public FDA source records.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0506-2022.

Recall Res Number
Z-0506-2022
Recalling Firm / Manufacturer
Philips North America Llc
FEI Number
3016618143
Recall Status
Open, Classified
Recall Classification
N/A
Date Initiated
2021-11-29
Date Posted
2022-01-19
Date Terminated
N/A
Product Code
IMD
Event Number
89163
Product Quantity
5,164,600 units
Product Description Infant Heel Warmers w/strap, Reference # 989805603201 1223
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 Details 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.
Distribution Pattern US Nationwide and Canada.
Code Information / Serial Numbers All units are impacted

Related Establishments / Registrations

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