FDA-Device2023-03-29Class II

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

DeRoyal Industries Inc
Hazard

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.

Sold states
US Nationwide distribution in the states of Arizona, Texas, Virginia, Pennsylvania, California, Missouri, North Carolina, Illinois, Indiana, Ohio, Arkansas.
Affected count
27,200 devices
Manufactured in
200 Debusk Ln, N/A, Powell, TN, United States
Products
DeRoyal SafeLiner Suction Canister, 1000cc, REF PHESL-1000B

Official notice

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

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