SNS Disposable Urethral Catheter Electrode Recalled for Sterilization Process Deviations
Spes Medica is recalling SNS Disposable Urethral Catheter Electrodes due to possible deviations in the ethylene oxide sterilization process. The recalled units may not be adequately sterilized, posing a potential infection risk to users.
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: The recall addresses a potential sterilization defect in an invasive medical device. No illnesses or injuries have been reported. Per the severity rubric, this constitutes a risk-of-harm product with no reported injury (Score 3: High).
Plain-English summary
Spes Medica is recalling SNS Disposable Urethral Catheter Electrodes (Reference Number UE006, 10 Fr) due to possible deviations in the ethylene oxide sterilization process. The supplier identified potential deviations in the sterilization parameters and processes defined for these devices, which could affect product sterility.
The affected lot is UR20F2702I, with 34 boxes distributed in California, Massachusetts, and South Carolina.
Consumers and healthcare facilities who have received the affected devices should contact Spes Medica for further instructions.
The recalled product
- Product
- SNS Disposable Urethral Catheter Electrode, 10 Fr, Gold Recording/Stimulating Contact printed on polyurethane film adhesive with attached 2 meter lead-wire with touch-proof connector, Reference Number UE006
- Manufacturer
- Spes Medica
- Affected units
- 34
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 UR20F2702I
Distribution
Part of a larger recall action
This product is one of 5 recalled by Spes Medica 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.
See all 5 products in this recall →Related recalls
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