evaluemed Infant Heel Warmer 301-1223; Distributed by Tri-anim A disposable heel warmer for use when circulation needs to be stimulated in the infant heel in order for blood sampling to occur
Reported: April 13, 2016 Initiated: February 10, 2016 #Z-1316-2016
Product Description
evaluemed Infant Heel Warmer 301-1223; Distributed by Tri-anim A disposable heel warmer for use when circulation needs to be stimulated in the infant heel in order for blood sampling to occur
Reason for Recall
eValueMed Infant Heel Warmers and eValueMed Infant Transport Mattresses bear no expiration date, nor any warning that product used beyond its expected shelf life may warm to temperature above its specification.
Details
- Recalling Firm
- Philips Electronics North America Corporation
- Units Affected
- 539.156
- Distribution
- Nationwide distribution to Ohio only.
- Location
- Andover, MA
Frequently Asked Questions
What product was recalled? ▼
evaluemed Infant Heel Warmer 301-1223; Distributed by Tri-anim A disposable heel warmer for use when circulation needs to be stimulated in the infant heel in order for blood sampling to occur. Recalled by Philips Electronics North America Corporation. Units affected: 539.156.
Why was this product recalled? ▼
eValueMed Infant Heel Warmers and eValueMed Infant Transport Mattresses bear no expiration date, nor any warning that product used beyond its expected shelf life may warm to temperature above its specification.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 13, 2016. Severity: Moderate. Recall number: Z-1316-2016.
Related Recalls
FDA Devices Moderate
Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.2…
Vortex Surgical Inc. · 2026-02-11
FDA Devices Moderate
COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conju…
Beckman Coulter, Inc. · 2026-02-11
FDA Devices Moderate
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Description: These inst…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 Product Description: These in…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Produc…
Fujirebio Diagnostics, Inc. · 2026-02-11