Summary
The FDA issued a Class II for SURGIFOAM" Absorbable Gelatin Powder Kit, Product Code 1979. by Ethicon, Inc.. Reason: Some applicator tips from these lots had open seals..
Details
Source
Device Recall
External ID
Z-1881-2024
Action Date
2024-05-29
Status
Ongoing
Category
device
Product Description
SURGIFOAM" Absorbable Gelatin Powder Kit, Product Code 1979.
Lot/Code Info: Product Number: 1979, UDI/DI: 15712123000264, Lot/Serial Numbers: 272574, 272369 and 272770.
Quantity Affected: 5,184 units
Reason for Recall
Some applicator tips from these lots had open seals.
Distribution
US Nationwide distribution in the states of AR, CA, FL, GA, ID, IL, IN, KY, MA, MD, MN, MO, NC, NE, NJ, PA, TN, TX, WI.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-04-23
Company
Somerville, NJ
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 291 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Ethicon, Inc. has 23 FDA actions in our database, including 15 recalls and 8 clearances.
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 (Ethicon, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Ethicon, Inc. have FDA actions?
Ethicon, Inc. has 23 FDA actions in our database, including 15 recalls and 8 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1881-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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