FDA-Device2014-10-29Class II
Suction canisters labels as follows: 1) DeRoyal(R) SUCTION CANISTER, 1000cc, SEMI-RIGID, REF 71-6510, NON-STERILE, Rx Only. 2) NOVAPLUS(TM) SUCTION CANISTER, 1000 cc, SEMI-RIGID, Cat. No. V71-6510, 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
13,900 units
Manufactured in
200 Debusk Ln, Powell, TN, United States
Products
Suction canisters labels as follows: 1) DeRoyal(R) SUCTION CANISTER, 1000cc, SEMI-RIGID, REF 71-6510, NON-STERILE, Rx Only. 2) NOVAPLUS(TM) SUCTION CANISTER, 1000 cc, SEMI-RIGID, Cat. No. V71-6510, NON-STERILE, Rx Only general hospital
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0097-2015Don't want to check this manually?
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