Medivance Neonatal ArcticGel Pads, REF: 31802, 3180202, 31802C
FDA device recall Z-1381-2024 · posted 2024-03-26 · Open, Classified
Recall details
- Recalling firm
- Medivance Inc.
- 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.
- 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.
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- DWJ
- Quantity affected
- 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
- Date initiated
- 2024-02-16
- Date posted
- 2024-03-26
- Location
- Louisville, CO
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Arctic Sun Temperature Management System, ArcticGel Pads (Universal, XXS, XS, S, M and L), Small Universal ArcticGel Pad, Neonatal ArcticGel Pad (K142702) | Medivance, Inc. | 2014-12-18 |