1050 STOPCOCK LEFT ROTATOR OFF HANDLE, List Number MX1431MRL
Reported: January 24, 2024 Initiated: November 10, 2023 #Z-0740-2024
Product Description
1050 STOPCOCK LEFT ROTATOR OFF HANDLE, List Number MX1431MRL
Reason for Recall
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.
Details
- Recalling Firm
- Smiths Medical Asd Inc
- Units Affected
- 31,685 total
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, UAE.
- Location
- Dublin, OH
Frequently Asked Questions
What product was recalled? ▼
1050 STOPCOCK LEFT ROTATOR OFF HANDLE, List Number MX1431MRL. Recalled by Smiths Medical Asd Inc. Units affected: 31,685 total.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 24, 2024. Severity: Moderate. Recall number: Z-0740-2024.
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