ECONO STERILE medical procedure kits labeled as: ECONO STERILE SIMS UTERINE SND GRD 13"STER25, Model Numbers: 96-247
Summary
The FDA issued a Class II for ECONO STERILE medical procedure kits labeled as: ECONO STERILE SIMS UTERINE S by Sklar Instruments. Reason: Reports of various packaging issues that may result in a breach of the sterile barrier..
Details
Source
Device Recall
External ID
Z-0928-2025
Action Date
2025-01-22
Status
Ongoing
Category
device
Product Description
ECONO STERILE medical procedure kits labeled as: ECONO STERILE SIMS UTERINE SND GRD 13"STER25, Model Numbers: 96-2478 (gynecological use)
Lot/Code Info: 96-2478, UDI/DI 50649111492615, Lot codes: SK-121
Quantity Affected: 0 units
Reason for Recall
Reports of various packaging issues that may result in a breach of the sterile barrier.
Distribution
Domestic: Nationwide Distribution
Type: Voluntary: Firm initiated
Recall Initiated: 2024-12-03
Company
West Chester, PA
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 249 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Sklar Instruments has 30 FDA actions in our database, including 30 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 (Sklar Instruments) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Sklar Instruments have FDA actions?
Sklar Instruments has 30 FDA actions in our database, including 30 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0928-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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