High Pressure Rotator with Female Luer Lock recall
HIGH PRESSURE ROTATOR WITH FEMALE LUER LOCK, List Number MX497HP
Why was High Pressure Rotator with Female Luer Lock recalled?
There is a manufacturing defect affecting specific rotator lots. Within this population, the inner diameter of the devices O-ring may be oversized affecting seal integrity. An inadequate seal may lead to a leak during infusion of medication which may potentially lead to under infusion of medication.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA 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?
Lot Number: 4330826 4384397
- Product
- HIGH PRESSURE ROTATOR WITH FEMALE LUER LOCK, List Number MX497HP
- Recalling firm
- Smiths Medical Asd Inc
- Quantity
- 31,685 total
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, UAE.
- Recall date
- January 24, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)