Degania Silicone, Ltd. recalls Silicone Fluted Round Drain 24Fr (hubless) & Connector, Sterile. Catalog Number JP-2234. Used for the drainage of body…
- Recall date
- October 3, 2017
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0899-2018
- FDA classification
- Class III
- Brand / firm
- Degania Silicone, Ltd.
- Sold / distributed
- US Distribution to Puerto Rico.
Why it was recalled
Sterile pouches are missing labels on them. The boxes themselves are properly labeled. The issue is related to the production lot P1607442 only.
Class III means the product violates regulations but is not likely to cause harm.
What was recalled
Silicone Fluted Round Drain 24Fr (hubless) & Connector, Sterile. Catalog Number JP-2234. Used for the drainage of body fluids for surgical use.
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