Medical Device Stopcock Recalled Due to O-Ring Seal Defect
Smiths Medical Asd Inc is recalling approximately 31,685 Stopcock Left Rotator devices due to oversized O-rings that may compromise seal integrity. The defect may cause medication leaks, potentially resulting in under-infusion during treatment.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of a medical device with a manufacturing defect affecting medication delivery. Although no illnesses or injuries have been reported, the potential for under-infusion of medication represents a risk of harm that qualifies for High severity under the rubric.
Plain-English summary
Smiths Medical Asd Inc has recalled the 1050 STOPCOCK LEFT ROTATOR OFF HANDLE (List Number MX1431MRL), specifically Lot Number 4387166. Approximately 31,685 units have been affected and distributed worldwide, including the United States, Canada, and the United Arab Emirates.
A manufacturing defect has been identified in these devices. The inner diameter of the O-ring may be oversized, which can affect the seal integrity of the stopcock. An inadequate seal may lead to leaks during medication infusion.
When medication is infused through a device with an inadequate seal, leakage can occur, potentially resulting in under-infusion of the intended medication dose to the patient. The FDA classified this as a Class II recall.
The recalled product
- Product
- 1050 STOPCOCK LEFT ROTATOR OFF HANDLE, List Number MX1431MRL
- Manufacturer
- Smiths Medical Asd Inc
- Affected units
- 31,685
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot Number: 4387166
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 9 recalled by Smiths Medical Asd Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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