FDA Device

Silicone Fluted Round Drain 24Fr (hubless) & Connector, Sterile. Catalog Number JP-2234. Used for the drainage of body fluids for surgical use.

Hazard

Sterile pouches are missing labels on them. The boxes themselves are properly labeled. The issue is related to the production lot P1607442 only.

What You Should Do

Remedy

An Urgent Medical Device Correction letter, dated October 03, 2017, was sent to the customer. The letter identified the affected device and the reason for the recall. The letter instructed the consignee to check its stock in order to remove all mislabeled product from the market and eliminate potential risk of misuse. The customer was instructed to return the completed Confirmation Sheet to Degania Silicone, as well as any unlabeled product. Questions regarding the recall should be directed to Katia Kayam, Customer Complaints Officer at Katia@ds-il.com.

Products

Silicone Fluted Round Drain 24Fr (hubless) & Connector, Sterile. Catalog Number JP-2234. Used for the drainage of body fluids for surgical use.
Brand
Degania Silicone, Ltd. Degania Bet Dganya Bet Israel
UPC
Lot No P1607442.

Units Affected

4,000 units