FDA recall Z-1881-2024

Ethicon, Inc. · Class II · device

Product

SURGIFOAM" Absorbable Gelatin Powder Kit, Product Code 1979.

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.

Key facts

Status
Ongoing
Initiation date
2024-04-23
Report date
2024-05-29
Voluntary/Mandated
Voluntary: Firm initiated
Location
Somerville, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1881-2024