Summit Medical Nasal Septal Button, Medium, 5cm, REF SP-78105, sterile.
Summary
The FDA issued a Class II for Summit Medical Nasal Septal Button, Medium, 5cm, REF SP-78105, sterile. by Summit Medical, LLC. Reason: Sterile product pouches were not sealed..
Details
Source
Device Recall
External ID
Z-1171-2023
Action Date
2023-03-08
Status
Ongoing
Category
device
Product Description
Summit Medical Nasal Septal Button, Medium, 5cm, REF SP-78105, sterile.
Lot/Code Info: Lot #219349, Exp. 2027-11-01, UDI (01)00385640065214(17)271101(10)219340
Quantity Affected: 30 devices
Reason for Recall
Sterile product pouches were not sealed.
Distribution
US Distribution was made to CO, FL, GA, LA, MA, and ME. There was no government/military distribution. OUS Foreign distribution was made to Canada.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-01-13
Company
Eagan, MN
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 149 device recalls issued in the same week, part of 403 device-related FDA actions this month.
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 (Summit Medical, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Summit Medical, LLC have FDA actions?
This is the only FDA action we have on record for Summit Medical, LLC in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1171-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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