Smiths Medical Injection Line Rotating Adapters Recalled for Seal Defect
Smiths Medical is recalling specific injection line rotating adapters due to a manufacturing defect causing oversized O-rings that may lead to inadequate seal integrity and medication under-infusion.
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 a risk-of-harm medical device where no injuries have been reported, consistent with a High severity classification. The manufacturing defect in the O-ring seal of a medication infusion device could lead to treatment failure through under-infusion, but the absence of reported illnesses limits the score below Severe.
Plain-English summary
Smiths Medical Asd Inc is recalling specific lot numbers (4383431, 4387987, 4404698) of its 48-inch injection line rotating adapters, rated at 900 psi. The product is a medical device component used in medication infusion systems.
The recall is due to a manufacturing defect affecting the O-ring seal. In affected units, the inner diameter of the O-ring is oversized, which compromises the seal integrity of the rotating adapter.
An inadequate seal may allow medication to leak during infusion, potentially resulting in under-infusion of medication. The product was distributed worldwide, including throughout the United States, Canada, and the United Arab Emirates, affecting a total of 31,685 units.
The FDA has classified this as a Class II recall.
The recalled product
- Product
- 48IN (121.9CM) INJ LINE ROTATING ADAPT (900psi), List Number MX694R
- Manufacturer
- Smiths Medical Asd Inc
- Category
- Medical Device
- 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: 4383431 4387987 4404698
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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