Device product
SURGIFOAM" Absorbable Gelatin Powder Kit, Product Code 1979.
Z-1881-2024
Product summary
- Firm
- Ethicon, Inc.
- Event
- Event 94496
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 5,184 units
- Official record key
device-enforcement:Z-1881-2024
Official wording
Reason: Some applicator tips from these lots had open seals.
Code information: Product Number: 1979, UDI/DI: 15712123000264, Lot/Serial Numbers: 272574, 272369 and 272770.
Distribution pattern: 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.
Derived failure modes
-
Unknown
Some applicator tips from these lots had open seals.