Tripolar Hooked Stimulation Probes recalled for ethylene oxide sterilization deviation
Spes Medica is recalling Tripolar Hooked Stimulation Probes due to possible deviations in the ethylene oxide sterilization process. The affected devices were distributed to healthcare facilities 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 a medical device recall involving a potential sterilization defect that could result in patient harm. The hazard poses a risk of serious injury from infection, and the rubric classifies risk-of-harm products without reported injury as a High severity. No illnesses or injuries have been reported, making this a theoretical risk-of-harm scenario.
Plain-English summary
Spes Medica has issued a recall of Tripolar Hooked Stimulation Probes (Reference Number SI3H0020S2526D, Lot SI20F2956I) used during intraoperative neurological monitoring. Three boxes of the device have been affected by this recall.
The recall was initiated after the supplier notified Spes Medica of possible deviations in the parameters and processes used for ethylene oxide sterilization of these devices. Proper sterilization is critical for medical devices used in surgical settings to prevent patient infection.
The affected devices were distributed to healthcare facilities in California, Massachusetts, and South Carolina.
Healthcare facilities that have received the affected Tripolar Hooked Stimulation Probes should contact Spes Medica for return or replacement instructions. No illnesses or injuries related to the use of these devices have been reported to date.
The recalled product
- Product
- Tripolar Hooked Stimulation Probes, L=20mm, Reference Number SI3H0020S2526D. Used during intraoperative neurological monitoring.
- Manufacturer
- Spes Medica
- Hazard
- improper-sterilization
- contamination-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 SI20F2956I
Distribution
Distributed in 3 states:
- CA
- MA
- SC
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