FDAClass IIMay 29, 2024

SURGIFOAM" Absorbable Gelatin Powder Kit recall

SURGIFOAM" Absorbable Gelatin Powder Kit, Product Code 1979.

Why was SURGIFOAM" Absorbable Gelatin Powder Kit recalled?

Some applicator tips from these lots had open seals.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Product Number: 1979, UDI/DI: 15712123000264, Lot/Serial Numbers: 272574, 272369 and 272770.

Product
SURGIFOAM" Absorbable Gelatin Powder Kit, Product Code 1979.
Recalling firm
Ethicon, Inc.
Quantity
5,184 units
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.
Recall date
May 29, 2024
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls