FDA-Device2018-03-14Class III
Silicone Fluted Round Drain 24Fr (hubless) & Connector, Sterile. Catalog Number JP-2234. Used for the drainage of body fluids for surgical use.
Degania Silicone, Ltd.
Hazard
Sterile pouches are missing labels on them. The boxes themselves are properly labeled. The issue is related to the production lot P1607442 only.
Sold states
US Distribution to Puerto Rico.
Affected count
4,000 units
Manufactured in
Degania Bet, N/A, Dganya Bet, N/A, Israel
Products
Silicone Fluted Round Drain 24Fr (hubless) & Connector, Sterile. Catalog Number JP-2234. Used for the drainage of body fluids for surgical use.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0899-2018Don't want to check this manually?
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