FDA Device recall Z-1395-2016
BARD ArcticGel Pads Product Usage: The Arctic Sun Temperature Management System is intended for monitoring and controlling patient temperat…
- FDA Device
- Class II
- terminated
- Published 2016-04-20
On 2016-04-20 the FDA classified a Class II recall of BARD ArcticGel Pads Product Usage: The Arctic Sun Temperature Management System is intended for monitoring and controlling patient temperat… by C R Bard, citing complaints were received of restricted/inaccurate flow rate.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1395-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-03-04 |
| Published | 2016-04-20 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | C R Bard |
| Distribution | US |
Product
BARD ArcticGel Pads Product Usage: The Arctic Sun Temperature Management System is intended for monitoring and controlling patient temperature. ArcticGel Pads are only for use with an Arctic Sun Temperature Management System Control Module.
Reason
Complaints were received of restricted/inaccurate flow rate.
Identifiers
| code_info | All lots with Catalog numbers: 31700 (Universal Pad), 3170004 (Universal Pad 4 pk), 31703 (XSmall pad kit), 3170302 (XS…All lots with Catalog numbers: 31700 (Universal Pad), 3170004 (Universal Pad 4 pk), 31703 (XSmall pad kit), 3170302 (XSmall pad kit 2 pk), 31705 (Small pad kit), 3170502 (Small pad kit 2 pk), 31707 (Medium pad kit), 3170702 (Medium pad kit 2 pk), 31709 (Large pad kit) and 3170902 (Large pad kit 2 pk), that are within their current expiration dates. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1395-2016%22
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