High Pressure Rotator Infusion Device Recalled Due to Seal Defect
Smiths Medical is recalling 31,685 HIGH PRESSURE ROTATOR infusion devices with a manufacturing defect that may cause an inadequate seal. The defect could lead to medication leaks and 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 an FDA Class II medical device recall involving a manufacturing defect that affects critical medication delivery. No illnesses or injuries have been reported, and the hazard is theoretical—the device may potentially cause under-infusion—placing this at High severity per the rubric.
Plain-English summary
Smiths Medical Asd Inc is recalling 31,685 HIGH PRESSURE ROTATOR WITH MALE LUER LOCK infusion devices (List Number MX496HP) due to a manufacturing defect affecting O-ring seal integrity.
The recalled devices have an oversized inner diameter in the O-ring, which may compromise the seal. An inadequate seal could allow medication to leak during infusion, potentially resulting in under-infusion of medication to patients.
The affected devices were distributed worldwide, including throughout the US, Canada, and the United Arab Emirates. The lot numbers involved are 4332915 and 4408772.
Patients and healthcare providers using affected devices should stop use and contact Smiths Medical for replacement or further guidance.
The recalled product
- Product
- HIGH PRESSURE ROTATOR WITH MALE LUER LOCK, List Number MX496HP
- 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: 4332915 4408772
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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