Medivance ArcticGel Neonatal Pad The pad is designed to fit into an incubator and provide whole body cooling for patient
FDA device recall Z-2345-2016 · posted 2016-08-05 · Terminated
Recall details
- Recalling firm
- C.R. Bard, Inc.
- 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.
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- DWJ
- Quantity affected
- 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
- Date initiated
- 2016-06-30
- Date posted
- 2016-08-05
- Date terminated
- 2017-06-06
- Location
- Covington, GA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Arctic Sun Temperature Management System, ArcticGel Pads (Universal, XXS, XS, S, M and L), Small Universal ArcticGel Pad, Neonatal ArcticGel Pad (K142702) | Medivance, Inc. | 2014-12-18 |