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Recall Observatory FDA recall evidence

Device product

Medivance ArcticGel Neonatal Pad The pad is designed to fit into an incubator and provide whole body cooling for patients.

Z-2345-2016

June 30, 2016

Class III

Product summary

Firm
C.R. Bard, Inc.
Event
Event 74609
Status
Terminated
Classification
Class III
Quantity
64
Official record key
device-enforcement:Z-2345-2016

Official wording

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.

Code information: Lot Numbers NGAN1721, NGAN1765, NGAP1807, NGAP2009, NGZK5402, NGZKY606, NGZKY607, NGZL3822

Distribution pattern: 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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.