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

FDA device recall Z-0899-2018 · posted 2018-02-20 · Terminated

Recall details

Recalling firm

Degania Silicone, Ltd.

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.

Action taken

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.

Root cause

Error in labeling

Status

Terminated

Product code

GBX

Quantity affected

4,000 units

Distribution

US Distribution to Puerto Rico.

Date initiated

2017-10-03

Date posted

2018-02-20

Date terminated

2020-10-21