FDA Device recall Z-2345-2016
Medivance ArcticGel Neonatal Pad The pad is designed to fit into an incubator and provide whole body cooling for patients
- FDA Device
- Class III
- terminated
- Published 2016-08-17
On 2016-08-17 the FDA classified a Class III recall of Medivance ArcticGel Neonatal Pad The pad is designed to fit into an incubator and provide whole body cooling for patients by C R Bard, citing an internal review of an available product found that the Information For Use only contained English and Japanese languages when a CE-marked 23 language version was expected.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2345-2016 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2016-06-30 |
| Published | 2016-08-17 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | C R Bard |
| Distribution | CA, FL, GA, IL, IN, MI, MN, MO, NY, OR, PA, TX, WA |
Product
Medivance ArcticGel Neonatal Pad The pad is designed to fit into an incubator and provide whole body cooling for patients.
Reason
An internal review of an available product found that the Information For Use only contained English and Japanese languages when a CE-marked 23 language version was expected.
Identifiers
| code_info | Lot Numbers NGAN1721, NGAN1765, NGAP1807, NGAP2009, NGZK5402, NGZKY606, NGZKY607, NGZL3822 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2345-2016%22
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