FDA-Device2024-05-29Class II

SURGIFOAM" Absorbable Gelatin Powder Kit, Product Code 1979.

Ethicon, Inc.
Hazard

Some applicator tips from these lots had open seals.

Sold states
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.
Affected count
5,184 units
Manufactured in
Us Highway 22 West, Somerville, NJ, United States
Products
SURGIFOAM" Absorbable Gelatin Powder Kit, Product Code 1979.

Official notice

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

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