Recall Z-1395-2016
C.R. Bard, Inc. · initiated March 4, 2016
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: 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.
Reason for recall
Complaints were received of restricted/inaccurate flow rate.
FDA-determined cause: Process control
Action taken
Bard Medical sent an Urgent Medical Product Recall letter dated March 4, 2016 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to not use any of the affected products and to return any unused product Bard Medical Division via the provided Customer Recall and Effectiveness Form. BMD will be providing a replacement for the returned product. If the product was further distributed, the consignee was instructed to identify their customers and notify them of the product recall.
Details
- Recall number
- Z-1395-2016
- Initiated
- March 4, 2016
- Terminated
- December 7, 2017
- Product code
- DWJ – System, Thermal Regulating
- Quantity
- 21,412 units
- Distribution
- Worldwide Distribution - Domestic: US Nationwide; Foreign: Argentina, Australia, Austria, Belarus, Belgium, Bosnia, Brazil Canada, Chile, China, Colombia, Croatia, Cyprus, Denmark, Egypt, Finland, France, Germany, Greece, Oman Kong, Iceland, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, , South Korea, Kuwait, Macedonia, Malaysia, Mexico, New Zealand, Norway, Oman…
- Recalling firm
- C.R. Bard, Inc., Covington, GA