CLASS III Device recall · Reported 17 Aug 2016 · FDA Enforcement Report
Medivance ArcticGel Neonatal Pad The pad is designed to fit recalled
C.R. Bard is recalling Medivance ArcticGel Neonatal Pad The pad is designed to fit into an incubator and provide, distributed in 13 states. The recall was initiated on 30 Jun 2016 and the FDA has classified it as Class III.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2345-2016
- FDA event ID
- 74609
- Recalling firm
- C.R. Bard, Covington, GA
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 30 Jun 2016
- FDA classified
- 5 Aug 2016
- Reported
- 17 Aug 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 30 Jun 2016 | Recall initiated by company | |
| 5 Aug 2016 | Classified by FDA | +36 days |
| 17 Aug 2016 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
Medivance ArcticGel Neonatal Pad The pad is designed to fit into an incubator and provide whole body cooling for patients.
Where it was distributed
US Distribution to the states of : CA, FL, GA, IL, IN, MI, MN, MO, NY, OR, PA, TX, WA, and Internationally to Germany, Italy and Switzerland
CaliforniaFloridaGeorgiaIllinoisIndianaMichiganMinnesotaMissouriNew YorkOregonPennsylvaniaTexasWashington
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Lot Numbers NGAN1721, NGAN1765, NGAP1807, NGAP2009, NGZK5402, NGZKY606, NGZKY607, NGZL3822
Where was it sold?
US Distribution to the states of : CA, FL, GA, IL, IN, MI, MN, MO, NY, OR, PA, TX, WA, and Internationally to Germany, Italy and Switzerland
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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