Silicone Fluted Round Drain 24Fr (hubless) & Connector, Sterile. Catalog Number JP-2234. Used for the drainage of body fluids for surgical use.
FDA Recall Z-0899-2018 · Posted 2018-02-20
Recalling FirmDegania Silicone, Ltd.
Recall StatusTerminated
Product CodeGBX
Date Initiated2017-10-03
Date Terminated2020-10-21
Product Quantity4,000 units
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.
Firm Action
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 [email protected].
Root Cause
Error in labeling
Distribution Pattern
US Distribution to Puerto Rico.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.