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Open, Classified

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

FDA Recall Z-1381-2024 · Posted 2024-03-26

Recalling FirmMedivance Inc.
Recall StatusOpen, Classified
Product CodeDWJ
Date Initiated2024-02-16
Product Quantity1,654

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.

Firm Action

On 2/16/24, BD mailed or emailed recall notices to customers who were asked to do the following: 1) Immediately Discontinue Use 2) Immediately quarantine affected pads, record your inventory totals on the Customer Response Form, discard all devices within your facility's control per your facility's procedures. 3) Share this notice with any users of the product within your facilities or with any facility affected product was distributed to. 4) Complete and return the attached Customer Response Form to the BD contact noted on the form. If you require further assistance contact BD Customer Support at 1-844-823-5433. Say "Recall" when prompted M-F 8am -5pm CT.

Root Cause

Process control

Distribution Pattern

Worldwide - US Nationwide distribution including in the states of IL, AL, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI, WV and the countries of Belgium, Australia, Singapore, South Korea, Taiwan, Japan, China, Thailand.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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