Recall Z-1381-2024
Medivance Inc. · initiated February 16, 2024
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Medivance Neonatal ArcticGel Pads, REF: 31802, 3180202, 31802C
Codes / lots: REF/UDI-DI/Lot(Expiration Date): 31802/00801741132131/NGGX5390(31Oct2024), NGGX1179(31Oct2024), NGGX1156(31Oct2024), NGHP2415(28Feb2025), NGHP2411(28Feb2025), NGHT1139(31May2025), NGHTY603(31May2025), NGHV4383(31Jul2025), NGHW1507(31Aug2025); 3180202/10801741132138/NGGZ2622(31Dec2024), NGGV1829(31Aug2024), NGGW3254(30Sep2024), NGHQ2940(31Mar2025); 31802C/00801741223457/NGGV1784(31Aug2024)
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.
FDA-determined cause: Process control
Action taken
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.
Details
- Recall number
- Z-1381-2024
- Initiated
- February 16, 2024
- Posted by FDA
- March 26, 2024
- Product code
- DWJ – System, Thermal Regulating
- 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, Taiwan, Japan, China, Thailand.
- Recalling firm
- Medivance Inc., Louisville, CO