| | Class 2 Device Recall EHOB Waffle Overlay |  |
| Date Initiated by Firm | June 09, 2020 |
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| Create Date | July 20, 2020 |
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| Recall Status1 |
Terminated 3 on January 25, 2021 |
| Recall Number | Z-2640-2020 |
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| Recall Event ID |
85870 |
| Product Classification |
Protector, skin pressure - Product Code FMP
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| Product | Expansion Control Overlay, Item No. 1004EC - Product Usage: The EHOB WAFFLE Overlay is more than a support surface, assisting in lateral transfers, boosts and turns to protect patients throughout the hospital journey. Through immersion and envelopment, the WAFFLE Overlay is designed to offload the patient and relieve pressure at bony prominences while the unique venting holes allow for air circulation to keep patients cool, dry and comfortable. |
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| Code Information |
Lot 93649FA |
Recalling Firm/
Manufacturer |
EHOB, Inc.
250 N Belmont Ave
Indianapolis IN 46222-4265
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| For Additional Information Contact | Scott Rogers
317-972-4600 |
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Manufacturer Reason
for Recall | QC inspection observed that a portion of the lot may have been contaminated with blood. |
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FDA Determined
Cause 2 | Process control |
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| Action | On June 9, 2020, the firm notified affected customers through VOLUNTARY MEDICAL DEVICE RECALL letters. Customers were advised that the affected lot of product may have been exposed to dried bodily fluids. Customers were instructed to not remove unused product from their boxes, nor to open sealed plastic bags that the products are contained in. The product is to be returned to the EHOB Indianapolis Distribution enter.
Please contact the firm's Customer Service department at customerservice@ehob.com or (317) 972-4600 to arrange free return shipment.
For additional information regarding this notice, you may contact Aaron Kadel, Vice President Engineering and Quality at (800) 899-5553; Monday Friday 9 AM 4 PM EST. |
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| Quantity in Commerce | 173 |
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| Distribution | US Nationwide distribution. |
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| 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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