Z-2407-2024 Class II Ongoing

Recalled by Ethicon Sarl, a Johnson & Johnson Company — Neuchatel

Recall Details

Product Type
Devices
Report Date
July 24, 2024
Initiation Date
June 11, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
39,010 units (All US)

Product Description

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 Pattern

Worldwide distribution - US Nationwide and the countries of India and Japan.

Code Information

Product Number: 1963; UDI/DI: 10705031003132 (primary), 20705031003139 (box of 10); Lot numbers: