Medivance ArcticGel Neonatal Pad Recalled for Missing Multilingual Instructions
C.R. Bard is recalling 64 Medivance ArcticGel Neonatal Pads because the included instructions were missing required languages for CE-marked products.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which the rubric defines as unlikely to cause adverse health consequences, and the issue is limited to documentation and labeling.
Plain-English summary
C.R. Bard, Inc. is recalling 64 units of the Medivance ArcticGel Neonatal Pad. This medical device is designed to fit into an incubator to provide whole-body cooling for patients. The recall was initiated after an internal review found that the Information For Use documentation only contained English and Japanese, whereas a CE-marked version was expected to include 23 languages.
The affected units were distributed in the United States to California, Florida, Georgia, Illinois, Indiana, Michigan, Minnesota, Missouri, New York, Oregon, Pennsylvania, and Texas. The products were also distributed internationally to Germany, Italy, and Switzerland. The specific lot numbers involved are NGAN1721, NGAN1765, NGAP1807, NGAP2009, NGZK5402, NGZKY606, NGZKY607, and NGZL3822.
This recall is classified as Class III by the FDA, indicating that the product is unlikely to cause adverse health consequences. Consumers and healthcare facilities should check their inventory for these specific lot numbers and contact the manufacturer for further instructions regarding the missing documentation.
The recalled product
- Product
- Medivance ArcticGel Neonatal Pad The pad is designed to fit into an incubator and provide whole body cooling for patients.
- Manufacturer
- C.R. Bard, Inc.
- Category
- Medical Device — Neonatal Care
- Hazard
- Affected units
- 64
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (8)
- Lot Numbers NGAN1721
- NGAN1765
- NGAP1807
- NGAP2009
- NGZK5402
- NGZKY606
- NGZKY607
- NGZL3822
Distribution
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