FDA recall Z-0899-2018

Degania Silicone, Ltd. · Class III · device

Product

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

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.

Distribution

US Distribution to Puerto Rico.

Key facts

Status
Terminated
Initiation date
2017-10-03
Report date
2018-03-14
Termination date
2020-10-21
Voluntary/Mandated
Voluntary: Firm initiated
Location
Dganya Bet, N/A, Israel

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0899-2018