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
Reported: July 7, 2021 Initiated: April 8, 2021 #Z-1968-2021
Product Description
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
Reason for Recall
The supplier informed them of possible deviations of the parameters/processes defined for ethylene oxide sterilization.
Details
- Recalling Firm
- Spes Medica
- Units Affected
- 34 boxes
- Distribution
- Distribution in the following US states: CA, MA, and SC.
- Location
- Genoa, N/A
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Spes Medica. Units affected: 34 boxes.
Why was this product recalled? ▼
The supplier informed them of possible deviations of the parameters/processes defined for ethylene oxide sterilization.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 7, 2021. Severity: Moderate. Recall number: Z-1968-2021.
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