DeRoyal SafeLiner Suction Canister, 1000cc, REF PHESL-1000B
FDA Recall #Z-1283-2023 — Class II — February 9, 2023
Product Description
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.
Recalling Firm
DeRoyal Industries Inc — Powell, TN
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
27,200 devices
Distribution
US Nationwide distribution in the states of Arizona, Texas, Virginia, Pennsylvania, California, Missouri, North Carolina, Illinois, Indiana, Ohio, Arkansas.
Code Information
GTIN 50749756377046, Lot 58447585 exp. 12/22/2027
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated