C.R. Bard, Inc.: Medical Device Recall in 2016 - (Recall #: Z-2345-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

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

Product Classification:

Class III

Date Initiated: June 30, 2016

Date Posted: August 17, 2016

Recall Number: Z-2345-2016

Event ID: 74609

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.

Status: Terminated

Product Quantity: 64

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

Voluntary or Mandated:

Voluntary: Firm initiated