SURGIFOAM Absorbable Gelatin Powder Kit Recalled for Open Applicator Tip Seals
Ethicon recalls SURGIFOAM Absorbable Gelatin Powder Kit (Product Code 1979) due to open seals on applicator tips in three lots. The recall affects 5,184 units distributed nationwide.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device with a genuine sterility and contamination risk from open seals on surgical applicator tips. However, no illnesses or injuries have been reported in the source text, which per the rubric caps the score at 3.
Plain-English summary
Ethicon, Inc. is recalling SURGIFOAM Absorbable Gelatin Powder Kit, Product Code 1979, due to open seals discovered on applicator tips from lots 272574, 272369, and 272770.
The affected 5,184 units were distributed nationwide across 18 states: Arkansas, California, Florida, Georgia, Idaho, Illinois, Indiana, Kentucky, Massachusetts, Maryland, Minnesota, Missouri, North Carolina, Nebraska, New Jersey, Pennsylvania, Tennessee, Texas, and Wisconsin.
Open seals on applicator tips compromise the sterile integrity of this surgical hemostatic device. If you have product from the affected lots, discontinue use and contact your supplier or Ethicon, Inc. for return or replacement instructions.
The recalled product
- Product
- SURGIFOAM" Absorbable Gelatin Powder Kit, Product Code 1979.
- Manufacturer
- Ethicon, Inc.
- Affected units
- 5,184
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Product Number: 1979
- UDI/DI: 15712123000264
- Lot/Serial Numbers: 272574
- 272369 and 272770.
Distribution
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