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
Reported: October 29, 2014 Initiated: August 22, 2014 #Z-0097-2015
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.
Details
- Recalling Firm
- DeRoyal Industries Inc
- Units Affected
- 13,900 units
- Distribution
- Nationwide Distribution including MI, OH, IN, FL, WV, VA, MI, NC, and NY
- Location
- Powell, TN
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by DeRoyal Industries Inc. Units affected: 13,900 units.
Why was this product recalled? ▼
These lots of suction canisters and lids have an insufficient seal under low or intermittent suction condition.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 29, 2014. Severity: Moderate. Recall number: Z-0097-2015.
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