FDA-Device2014-10-29Class II

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

DeRoyal Industries Inc
Hazard

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

Sold states
Nationwide Distribution including MI, OH, IN, FL, WV, VA, MI, NC, and NY
Affected count
5112 units
Manufactured in
200 Debusk Ln, Powell, TN, United States
Products
DeRoyal(R) SafeLiner Suction Canister Kit, SEMI-RIGID, 1000cc, REF 71-6518, NON-STERILE, Rx Only, general hospital

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0098-2015

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