PlainRecalls
FDA Devices Moderate Class II Terminated

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.