FDA recall Z-2407-2024

Ethicon Sarl, a Johnson & Johnson Company · Class II · device

Product

SURGICEL FIBRILLAR 1INX2IN(2.5CMX5.1CM), Product Number: 1963

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.

Key facts

Status
Ongoing
Initiation date
2024-06-11
Report date
2024-07-24
Voluntary/Mandated
Voluntary: Firm initiated
Location
Neuchatel, Switzerland

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2407-2024