Degania Silicone, Ltd.: Medical Device Recall in 2018 - (Recall #: Z-0899-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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

Product Classification:

Class III

Date Initiated: October 3, 2017

Date Posted: March 14, 2018

Recall Number: Z-0899-2018

Event ID: 79199

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.

Status: Terminated

Product Quantity: 4,000 units

Code Information:

Lot No P1607442.

Distribution Pattern:

US Distribution to Puerto Rico.

Voluntary or Mandated:

Voluntary: Firm initiated