Recall Z-0097-2015— DeRoyal Industries Inc
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: 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. 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
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
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.