Z-1881-2024 Class II Ongoing
FDA device recall Z-1881-2024 was initiated by Ethicon, Inc. on April 23, 2024 and is designated Class II. Reason for recall: Some applicator tips from these lots had open seals. The recall status is ongoing. Affected quantity: 5,184 units.
Recall Details
- Product Type
- Devices
- Report Date
- May 29, 2024
- Initiation Date
- April 23, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5,184 units
Product Description
SURGIFOAM" Absorbable Gelatin Powder Kit, Product Code 1979.
Reason for Recall
Some applicator tips from these lots had open seals.
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.
Code Information
Product Number: 1979, UDI/DI: 15712123000264, Lot/Serial Numbers: 272574, 272369 and 272770.