| 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-1184-2017 |
Recall Event ID |
75939 |
Product Classification |
Bed, therapeutic, ac-powered, adjustable home-use - Product Code LLI
|
Product | Foot Section - BAR5490IVC |
Code Information |
BAR5490IVC |
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 | A quality issue with the junction box used in the bariatric bed junction that may omit sparks and result into 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 | 292 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 |
|
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.
|
|
|
|