Recall Z-1381-2024— Medivance Inc.

Name: FDA recall Z-1381-2024
Creator: U.S. Food and Drug Administration
Published: 2024-02-16

Class II · Ongoing

Class II FDA medical device recall by Medivance Inc., initiated 2024-02-16. It names one FDA 510(k) clearance: K142702. Product: Medivance Neonatal ArcticGel Pads, REF: 31802, 3180202, 31802C. Reason: Neonatal pads are experiencing reduced water flow, which may reduce or prevent water heating or cooling performance of the pads that are part of a temperature management system..

Recalling firm: Medivance Inc.
Classification: Class II
Status: Ongoing
Initiated: 2024-02-16
Firm location: Louisville, CO, United States

510(k) clearances named in this recall

1 on FDA's record

K142702 — Arctic Sun Temperature Management System, ArcticGel Pads (Universal, XXS, XS, S, M and L), Small Universal ArcticGel Pad, Neonatal ArcticGel PadMedivance, Inc.·cleared 2014-12-18

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Medivance Neonatal ArcticGel Pads, REF: 31802, 3180202, 31802C

Reason for recall

Neonatal pads are experiencing reduced water flow, which may reduce or prevent water heating or cooling performance of the pads that are part of a temperature management system.

Data sourced from openFDA. This site is unofficial and independent of the FDA.