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Recall Observatory FDA recall evidence

Device product

SURGIFOAM" Absorbable Gelatin Powder Kit, Product Code 1979.

Z-1881-2024

April 23, 2024

Class II

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

    reason.no_named_rule · v1.0.0

    Some applicator tips from these lots had open seals.