FDA recall Z-2144-2024

Ethicon, Inc. · Class II · device

Product

VICRYL (polyglactin 910) Suture - Indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic surgery, but not for use in cardiovascular and neurological tissues. PRODUCT CODE: J214H J218H J258H J268H J269H J327H J344H J345H J370H J416H J417H J426H J427H J458H J493H J603H J699H J936H J978H

Reason for recall

Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .

Distribution

Worldwide distribution - US Nationwide including PR and the countries of AR, AU, AU, BE, BR, CA, CA, CL, CN, CO, CR, EC, IL, JP, JP, KW, MX, NZ, PA, PR, PR, SA, SG, UY, ZA.

Key facts

Status
Ongoing
Initiation date
2024-05-10
Report date
2024-06-26
Voluntary/Mandated
Voluntary: Firm initiated
Location
Raritan, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2144-2024