SNS Disposable Urethral Catheter Electrode Recalled for Sterilization Process Deviations
Spes Medica has recalled SNS Disposable Urethral Catheter Electrodes due to possible deviations in ethylene oxide sterilization processes. The recall affects one lot distributed in California, Massachusetts, and South Carolina.
What this means for you
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 sterilization process deviation. While no illnesses or injuries have been reported, the potential compromise of sterility in a urological catheter represents a risk-of-harm product; accordingly, this meets the criteria for a High severity rating.
Plain-English summary
Spes Medica is recalling SNS Disposable Urethral Catheter Electrodes, Reference Number UE002, lot UR20F2699I (30 boxes of 14 Fr), due to possible deviations in ethylene oxide sterilization parameters and processes.
The supplier informed Spes Medica of these possible deviations affecting the ethylene oxide sterilization process. Sterilization is critical for medical devices used in urological procedures, and deviations in sterilization parameters could potentially affect the sterility assurance of the affected units.
The recalled products were distributed to healthcare facilities in California, Massachusetts, and South Carolina.
The recalled product
- Product
- SNS Disposable Urethral Catheter Electrode, 14 Fr, Gold Recording/Stimulating Contact printed on polyurethane film adhesive with attached 2 meter lead-wire with touch-proof connector, Reference Number UE002
- Manufacturer
- Spes Medica
- Hazard
- sterilization-deviation
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 UR20F2699I
Distribution
Distributed in 3 states:
- CA
- MA
- SC
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