FDA recall Z-1283-2023

DeRoyal Industries Inc · Class II · device

Product

DeRoyal SafeLiner Suction Canister, 1000cc, REF PHESL-1000B

Reason for recall

The reason for the voluntary recall is due to shrinkage of the canister lid. This shrinkage causes the lid not to contact the outer shell to create a seal and thus, it does not create and hold vacuum.

Distribution

US Nationwide distribution in the states of Arizona, Texas, Virginia, Pennsylvania, California, Missouri, North Carolina, Illinois, Indiana, Ohio, Arkansas.

Key facts

Status
Ongoing
Initiation date
2023-02-09
Report date
2023-03-29
Voluntary/Mandated
Voluntary: Firm initiated
Location
Powell, TN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1283-2023