Medical device recalls

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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