Recall Z-1381-2024 ยท DWJ System, Thermal Regulating
Medivance Inc.
Medivance Neonatal ArcticGel Pads, REF: 31802, 3180202, 31802C
| Date | Mar 26, 2024 (initiated Feb 16, 2024) |
| Status | Open, Classified |
| 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. |
| Root cause | Process control |
| 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 Suppor |
| Quantity | 1,654 |
| Distribution | 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, Ta |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K142702 | Arctic Sun Temperature Management System, ArcticGel Pads (Universal, XXS, XS, S, M and L), Small Universal ArcticGel Pad Medivance, Inc., Dec 18, 2014 |