Reported Aug 17, 2016 · Terminated
Medivance ArcticGel Neonatal Pad The pad is designed to fit into an incubator and provide whole body cooling for…
C.R. Bard, Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: C.R. Bard, Inc. · 8195 Industrial Blvd NE · Covington, GA · 30014-1497
Is this the product you have?
- Medivance ArcticGel Neonatal Pad The pad is designed to fit into an incubator and provide whole body cooling for patients.
- Lot codes and dates
Lot Numbers NGAN1721NGAN1765NGAP1807NGAP2009NGZK5402NGZKY606NGZKY607NGZL3822
- Amount recalled
- 64
Where it was sold
Why it was 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.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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