FDA Recalls Medical Pressure Tubing With Defective O-Ring Seals
Smiths Medical is recalling 31,685 units of pressure tubing with defective O-rings that may not seal properly during medication infusion, potentially causing medication leaks and underdosing. The defect affects specific lot numbers with worldwide distribution.
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 recall with a manufacturing defect that may compromise medication delivery through seal failure, potentially leading to patient underdosing. This represents a significant risk in a medical device context.
Plain-English summary
Smiths Medical Asd Inc is recalling 31,685 units of 6-inch pressure tubing (List Number MX20617) due to a manufacturing defect affecting the product's seal integrity.
The affected devices contain an oversized inner diameter in the O-ring component. This manufacturing defect may cause inadequate seal performance during medication infusion, which could result in medication leaks and lead to under infusion of medication.
The recall applies to tubing with lot numbers 4380614 and 4416451. The affected products have been distributed worldwide, including the United States, Canada, and the United Arab Emirates.
The recalled product
- Product
- 6IN PRESSURE TUBING, List Number MX20617
- 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 (2)
- Lot Number: 4380614
- 4416451
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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