Recall Z-1283-2023— DeRoyal Industries Inc

Name: FDA recall Z-1283-2023
Creator: U.S. Food and Drug Administration
Published: 2023-02-09

Class II · Ongoing

Class II FDA medical device recall by DeRoyal Industries Inc, initiated 2023-02-09. FDA's recall record names no specific 510(k) clearance for this event. Product: DeRoyal SafeLiner Suction Canister, 1000cc, REF PHESL-1000B. Reason: 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
Classification: Class II
Status: Ongoing
Initiated: 2023-02-09
Firm location: Powell, TN, United States

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.