Recall Z-0098-2015— DeRoyal Industries Inc

Name: FDA recall Z-0098-2015
Creator: U.S. Food and Drug Administration
Published: 2014-08-22

Class II · Terminated

Class II FDA medical device recall by DeRoyal Industries Inc, initiated 2014-08-22, terminated 2015-04-15. FDA's recall record names no specific 510(k) clearance for this event. Product: DeRoyal(R) SafeLiner Suction Canister Kit, SEMI-RIGID, 1000cc, REF 71-6518, NON-STERILE, Rx Only, general hospital. Reason: These lots of suction canisters and lids have an insufficient seal under low or intermittent suction condition..

Recalling firm: DeRoyal Industries Inc
Classification: Class II
Status: Terminated
Initiated: 2014-08-22
Terminated: 2015-04-15
Firm location: Powell, TN, United States

Product description

DeRoyal(R) SafeLiner Suction Canister Kit, SEMI-RIGID, 1000cc, REF 71-6518, NON-STERILE, Rx Only, general hospital

Reason for recall

These lots of suction canisters and lids have an insufficient seal under low or intermittent suction condition.

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