Arctic Sun 5000 and Arctic Sun 2000; Intended for monitoring and controlling patient temperatures.
FDA device recall Z-0760-2016 · posted 2016-02-05 · Terminated
Recall details
- Recalling firm
- C.R. Bard, Inc.
- Reason for recall
- Improper targeted temperature therapy was delivered to patients because the Temperature Simulator Key was connected to the patient temperature cable instead of the patient temperature probe.
- Action taken
- Bard Medical Division sent a Safety Alert to each of the customers via FedEx with proof of delivery notice. All consignees have been instructed to carry the notification out to the user-level.
- Root cause
- Use error
- Status
- Terminated
- Product code
- DWJ
- Quantity affected
- 1,539
- Distribution
- Nationwide Distribution-DC and the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI. IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD,
- Date initiated
- 2015-11-10
- Date posted
- 2016-02-05
- Date terminated
- 2017-04-21
- Location
- Covington, GA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 5000 (K101092) | Medivance, Inc. | 2010-07-16 |
| MODIFICATION TO ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 2000 (K071341) | Medivance, Inc. | 2007-08-03 |