Z-0899-2018Class III

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

Name: Z-0899-2018 Silicone Fluted Round Drain 24Fr (hubless) & Connector, Sterile. Catalog Number JP-2234. Used for the...
Creator: Degania Silicone, Ltd.
Published: 2017-10-03
License: https://open.fda.gov/license/

Degania Silicone, Inc. / initiated 2017-10-03 / Terminated / root cause: labeling and UDI

FDA source

Degania Silicone, Ltd. began a recall of Silicone Fluted Round Drain 24Fr (hubless) & Connector, Sterile. Catalog Number JP-2234. Used for the drainage of body fluids for surgical use on 2017-10-03. FDA classified it as Class III and gives the reason as "Sterile pouches are missing labels on them. The boxes themselves are properly labeled. The issue is related to the production lot P1607442 only". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0899-2018
Classification: Class III
Status: Terminated
Initiated: 2017-10-03
Posted: 2018-02-20
Terminated: 2020-10-21
Recalling firm: Degania Silicone, Inc.
Product: Silicone Fluted Round Drain 24Fr (hubless) & Connector, Sterile. Catalog Number JP-2234. Used for the drainage of body fluids for surgical use.
Product code: GBX Catheter, Irrigation
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.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
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].
Quantity in commerce: 4,000 units
Distribution: US Distribution to Puerto Rico.
Product codes and lots: Lot No P1607442.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0899-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0899-2018	Class III	Terminated	Voluntary: Firm initiated	2018-03-14	2018-03-05

Product code GBX

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)