—#148027

Product

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

FDA product code: DWJ — System, Thermal Regulating
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K142702
Affected lot / code info: Lot Numbers NGAN1721, NGAN1765, NGAP1807, NGAP2009, NGZK5402, NGZKY606, NGZKY607, NGZL3822

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.

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: C.R. Bard, Inc.
Address: 8195 Industrial Blvd NE, Covington, Georgia 30014-1497

Distribution

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

Timeline

Recall initiated: 2016-06-30
Posted by FDA: 2016-08-05
Terminated: 2017-06-06
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #148027. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.