FDA Enforcement
Class II
Ongoing
SURGIFOAM" Absorbable Gelatin Powder Kit, Product Code 1979.
Recall: Z-1881-2024
·
Reported May 29, 2024
Enforcement
- Recall Number
- Z-1881-2024
- Event ID
- 94496
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Ethicon, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- May 29, 2024
- Initiation Date
- April 23, 2024
- Classification Date
- May 22, 2024
- Address
- Us Highway 22 West, Somerville, NJ, 08876, United States
Description
SURGIFOAM" Absorbable Gelatin Powder Kit, Product Code 1979.
Reason
Some applicator tips from these lots had open seals.
Code Info
Product Number: 1979, UDI/DI: 15712123000264, Lot/Serial Numbers: 272574, 272369 and 272770.
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.
Quantity
5,184 units