Braided Injection Line Recalled for Potential Medication Leaks
Smiths Medical is recalling approximately 31,685 units of a braided injection line due to manufacturing defects in the O-ring seal. The defect may cause medication leaks that reduce drug delivery.
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: FDA Class II medical device with a real manufacturing defect affecting device function. The potential hazard is medication leakage and under-infusion, but the source text reports no illnesses or injuries. Per the rubric, a risk-of-harm product where injury has not yet been reported scores High (3).
Plain-English summary
Smiths Medical Asd Inc is recalling approximately 31,685 units of its 20-inch braided injection line with rotating adapter (List Number MX682BR) from specific production lots. The recall stems from a manufacturing defect affecting the O-ring seal component. On some units, the O-ring's inner diameter is oversized, compromising the seal's integrity.
An inadequate seal may allow medication to leak during infusion. This can result in under-infusion, meaning patients may receive less medication than intended, potentially compromising treatment effectiveness.
The affected lots (4398428 and 4404690) were distributed worldwide, including throughout the United States, Canada, and the United Arab Emirates. Facilities and healthcare providers using these product lots should immediately cease use and contact Smiths Medical for instructions on replacement or return. No illnesses or injuries have been reported to date.
The recalled product
- Product
- 20IN (50.8CM) BRAIDED INJ LINE, ROTATING ADAPT, List Number MX682BR
- 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: 4398428 4404690
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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