Reported Mar 14, 2018 · Terminated
Silicone Fluted Round Drain 24Fr (hubless) & Connector, Sterile. Catalog Number JP-2234. Used for the drainage of body…
Degania Silicone, Ltd.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Degania Silicone, Ltd. · Degania Bet · Dganya Bet, N/A · N/A
Is this the product you have?
- Silicone Fluted Round Drain 24Fr (hubless) & Connector, Sterile. Catalog Number JP-2234. Used for the drainage of body fluids for surgical use.
- Lot codes and dates
- Lot No P1607442.
- Amount recalled
- 4,000 units
Where it was sold
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.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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