SNS Disposable Urethral Catheter Electrode, 14 Fr, Gold Recording/Stimulating Contact printed on polyurethane film adhes
Summary
The FDA issued a Class II for SNS Disposable Urethral Catheter Electrode, 14 Fr, Gold Recording/Stimulating Co by Spes Medica. Reason: The supplier informed them of possible deviations of the parameters/processes defined for ethylene oxide sterilization..
Details
Source
Device Recall
External ID
Z-1970-2021
Action Date
2021-07-07
Status
Terminated
Category
device
Product Description
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
Lot/Code Info: Lot UR20F2699I
Quantity Affected: 30 boxes
Reason for Recall
The supplier informed them of possible deviations of the parameters/processes defined for ethylene oxide sterilization.
Distribution
Distribution in the following US states: CA, MA, and SC.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-04-08
Company
Genoa, N/A
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 52 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Spes Medica has 5 FDA actions in our database, including 5 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Spes Medica) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Spes Medica have FDA actions?
Spes Medica has 5 FDA actions in our database, including 5 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1970-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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