Arctic Sun 5000 Temperature Management System, 100-120 V North America and 100-120 V US
FDA device recall Z-3042-2017 · posted 2017-08-16 · Terminated
Recall details
- Recalling firm
- C.R. Bard, Inc.
- Reason for recall
- Potential failure of the Arctic Sun 5000 Temperature Management System may occur when the continued use is in excess of 2000 system hours without preventive maintenance.
- Action taken
- Bard sent an Urgent Customer Notification letter dated March 31, 2017, to each of the U.S. consignees. The letter contained recommended actions and included an Acknowledgement Form to be returned. For further questions, please call (770) 784-6119.
- Root cause
- Unknown/Undetermined by firm
- Status
- Terminated
- Product code
- DWJ
- Quantity affected
- 3,450 units
- Distribution
- Worldwide Distribution - USA (nationwide) to the states of :AL, AK, AZ, AR, CA, CO, CT, DE, DC, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, O
- Date initiated
- 2017-03-31
- Date posted
- 2017-08-16
- Date terminated
- 2017-08-28
- Location
- Covington, GA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 5000 (K101092) | Medivance, Inc. | 2010-07-16 |