Medivance ArcticGel Neonatal Pad The pad is designed to fit into an… — Class III medical device recall Z-2345-2016
Terminated recall by C.R. Bard, Inc., reported 2016-08-17, distributed in CA, FL, GA, IL, IN, MI, MN, MO…. An internal review of an available product found that the Information For Use only contained English and Japan
| Recall number | Z-2345-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | C.R. Bard, Inc., Covington, GA, United States |
| Recall initiated | 2016-06-30 |
| Classified | 2016-08-05 |
| Reported by FDA | 2016-08-17 |
| Terminated | 2017-06-06 |
| Distributed | CA, FL, GA, IL, IN, MI, MN, MO, NY, OR, PA, TX, WA |
| Countries outside the US | CH, DE, IT |
| Quantity | 64 |
| Lot numbers | NGAN1721, NGAN1765, NGAP1807, NGAP2009, NGZK5402, NGZKY606, NGZKY607, NGZL3822 |
Product
Medivance ArcticGel Neonatal Pad The pad is designed to fit into an incubator and provide whole body cooling for patients.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2345-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.