Medivance ArcticGel Neonatal Pad The pad is designed to recall
Medivance ArcticGel Neonatal Pad The pad is designed to fit into an incubator and provide whole body cooling for patients.
Why was Medivance ArcticGel Neonatal Pad The pad is designed to 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot Numbers NGAN1721, NGAN1765, NGAP1807, NGAP2009, NGZK5402, NGZKY606, NGZKY607, NGZL3822
- Product
- Medivance ArcticGel Neonatal Pad The pad is designed to fit into an incubator and provide whole body cooling for patients.
- Recalling firm
- C.R. Bard, Inc.
- 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
- Recall date
- August 17, 2016
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (device)