Reported Jul 7, 2021 · Terminated
SNS Disposable Urethral Catheter Electrode, 10 Fr, Gold Recording/Stimulating Contact printed on polyurethane film…
Spes Medica
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Spes Medica · Via Buccari 21 · Genoa, N/A · N/A
Is this the product you have?
- 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
- Lot codes and dates
- Lot UR20F2702I
- Amount recalled
- 34 boxes
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 are below.
Where it was sold
Why it was recalled
The supplier informed them of possible deviations of the parameters/processes defined for ethylene oxide sterilization.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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