IVEA 500A Intended for Med-Surg patient care recall
IVEA 500A Intended for Med-Surg patient care.
Why was IVEA 500A Intended for Med-Surg patient care recalled?
The dowel pin could potentially slip out of its press fit, resulting in the product potentially slumping to one side which could cause the patient to stumble.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Product Part Number 16100. Serial Numbers 100200-101068, except for serial numbers within this range not released into final inventory for other reasons.
- Product
- IVEA 500A Intended for Med-Surg patient care.
- Recalling firm
- Firefly Medical, Inc.
- Quantity
- 239
- Distribution
- Worldwide Distribution -- USA and Canada.
- Recall date
- December 21, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)