Reported Apr 20, 2016 · Terminated
BARD ArcticGel Pads Product Usage: The Arctic Sun Temperature Management System is intended for monitoring and…
C.R. Bard, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: C.R. Bard, Inc. · 8195 Industrial Blvd NE · Covington, GA · 30014-1497
Is this the product you have?
- BARD ArcticGel Pads Product UsageThe 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
- Lot codes and dates
- All lots with Catalog numbers31700 (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
- Amount recalled
- 21,412 units
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
- Nationwide
Why it was recalled
Complaints were received of restricted/inaccurate flow rate.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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