Recall Z-2345-2016
C.R. Bard, Inc. · initiated June 30, 2016
Class III – products unlikely to cause any adverse health reaction but that violate FDA labeling or manufacturing laws
Product
Medivance ArcticGel Neonatal Pad The pad is designed to fit into an incubator and provide whole body cooling for patients.
Codes / lots: Lot Numbers NGAN1721, NGAN1765, NGAP1807, NGAP2009, NGZK5402, NGZKY606, NGZKY607, NGZL3822
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.
FDA-determined cause: Other
Action taken
A Customer Communication Correction Letter was sent to customers on June 30, 2016. The letter requested that they examine inventory and remove the original IFU and substitute a copy of the IFU that was included with the Correction letter. The letter also requested a sub-recall, and included a reply form which was to be completed and returned. If you have any further questions please call (401) 825-8690.
Details
- Recall number
- Z-2345-2016
- Initiated
- June 30, 2016
- Posted by FDA
- August 5, 2016
- Terminated
- June 6, 2017
- Product code
- DWJ – System, Thermal Regulating
- Quantity
- 64
- Distribution
- 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
- Recalling firm
- C.R. Bard, Inc., Covington, GA