Arctic Sun Temperature Management System, 5000, 100-120V and 220-240V The product is a thermal regulating system indicat
FDA device recall Z-1617-2016 · posted 2016-05-06 · Terminated
Recall details
- Recalling firm
- C.R. Bard, Inc.
- Reason for recall
- The product may contain electronic components that lead to a premature drainage of the internal control panel coin cell battery responsible for maintaining the system close and Static Random Access Memory (SRAM). This premature coin cell battery drainage could render the device unresponsive upon System startup.
- Action taken
- BARD sent an Urgent Medical Product Recall to all affected consignees on November 9, 2015. The letter indicates that a technician will contract the firm for the evaluation and potential replacement of the affected electronic components. The technician will fill out the Field Action Effectiveness Check Form after evaluation. Customers with questions were instructed to call 1-770-784-6471 or email bmd@crbard.com. For questions regarding this recall call 770-784-6220.
- Root cause
- Unknown/Undetermined by firm
- Status
- Terminated
- Product code
- DWJ
- Quantity affected
- 2613
- Distribution
- Worldwide Distribution to AL, AK, AZ, AR, CA, CO, CT, DEL, DC, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NH, NV, NH, NJ, NM, NY, NC, OH, OK, OR, PA, SC, SD, TN, TX, U
- Date initiated
- 2015-11-09
- Date posted
- 2016-05-06
- Date terminated
- 2017-06-06
- 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 |