1050 Stopcock Left Rotator OFF Handle recall
1050 STOPCOCK LEFT ROTATOR OFF HANDLE, List Number MX1431MRL
Why was 1050 Stopcock Left Rotator OFF Handle 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: 4387166
- Product
- 1050 STOPCOCK LEFT ROTATOR OFF HANDLE, List Number MX1431MRL
- 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)