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Class 2 Device Recall Bariatric Bed |
 |
| Date Initiated by Firm |
December 02, 2016 |
| Create Date |
February 09, 2017 |
| Recall Status1 |
Terminated 3 on November 02, 2017 |
| Recall Number |
Z-1182-2017 |
| Recall Event ID |
75939 |
| Product Classification |
Bed, therapeutic, ac-powered, adjustable home-use - Product Code LLI
|
| Product |
Bariatric Bed - BAR600IVC |
| Code Information |
BAR600IVC |
Recalling Firm/
Manufacturer |
Invacare Corporation
1 Invacare Way
Elyria OH 44035-4190
|
| For Additional Information Contact |
Janet Bonness
440-329-6768
|
Manufacturer Reason
for Recall |
The junction box used in the bariatric bed may emit sparks and result in a fire.
|
FDA Determined
Cause 2 |
Component design/selection |
| Action |
All customers were notified via letter with return receipt. This notification will include a provider letter, provider response card, impacted unit list and a consumer letter. Consignees will be instructed conduct sub-recalls as necessary. Follow-up telephone calls will be made to nonresponders. |
| Quantity in Commerce |
411 Units |
| Distribution |
Products were distributed in the following states: AK, AL, AR, CA, CO, CT, FL, HI, ID, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO, MS, NC, NJ, NM, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, and WI.
No foreign accounts |
| Total Product Life Cycle |
TPLC Device Report
|
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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