Recall Z-0899-2018— Degania Silicone, Ltd.
Class III · Terminated
Class III FDA medical device recall by Degania Silicone, Ltd., initiated 2017-10-03, terminated 2020-10-21. FDA's recall record names no specific 510(k) clearance for this event. Product: Silicone Fluted Round Drain 24Fr (hubless) & Connector, Sterile. Catalog Number JP-2234. Used for the drainage of body fluids for surgical use.. Reason: Sterile pouches are missing labels on them. The boxes themselves are properly labeled. The issue is related to the production lot P1607442 only..
- Recalling firm
- Degania Silicone, Ltd.
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2017-10-03
- Terminated
- 2020-10-21
- Firm location
- Dganya Bet, N/A, Israel
Product description
Silicone Fluted Round Drain 24Fr (hubless) & Connector, Sterile. Catalog Number JP-2234. Used for the drainage of body fluids for surgical use.
Reason for recall
Sterile pouches are missing labels on them. The boxes themselves are properly labeled. The issue is related to the production lot P1607442 only.
Data sourced from openFDA. This site is unofficial and independent of the FDA.