SURGICEL FIBRILLAR 1INX2IN(2.5CMX5.1CM), Product Number: 1963
Summary
The FDA issued a Class II for SURGICEL FIBRILLAR 1INX2IN(2.5CMX5.1CM), Product Number: 1963 by Ethicon Sarl, a Johnson & Johnson Company. Reason: Some foil pouches were found torn open, impacting the sterile barrier which was traced to a specific machine used during product packaging..
Details
Source
Device Recall
External ID
Z-2407-2024
Action Date
2024-07-24
Status
Ongoing
Category
device
Product Description
SURGICEL FIBRILLAR 1INX2IN(2.5CMX5.1CM), Product Number: 1963
Lot/Code Info: Product Number: 1963; UDI/DI: 10705031003132 (primary), 20705031003139 (box of 10); Lot numbers:
Quantity Affected: 39,010 units (All US)
Reason for Recall
Some foil pouches were found torn open, impacting the sterile barrier which was traced to a specific machine used during product packaging.
Distribution
Worldwide distribution - US Nationwide and the countries of India and Japan.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-06-11
Company
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 198 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Ethicon Sarl, a Johnson & Johnson Company has 2 FDA actions in our database, including 2 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 (Ethicon Sarl, a Johnson & Johnson Company) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Ethicon Sarl, a Johnson & Johnson Company have FDA actions?
Ethicon Sarl, a Johnson & Johnson Company has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2407-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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