The Recall Desk
HighFDA (Devices)·Z-1968-2021·Announced 2021-07-07

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.

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: 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
Category
Medical Device — Urinary Catheter
Hazard
  • sterilization-defect
  • infection-risk

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

Distributed in 3 states:

  • CA
  • MA
  • SC

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