FDAFDA · Food and drugs·Recall number Z-0097-2015
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
Published October 29, 2014 · Recall initiated: August 22, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
These lots of suction canisters and lids have an insufficient seal under low or intermittent suction condition.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- DeRoyal Industries Inc
- Distributor
- Nationwide Distribution including MI, OH, IN, FL, WV, VA, MI, NC, and NY
- Lot
- 1) DeRoyal(R), REF 71-6510, Lot 36408631 2) NOVAPLUS(TM) Cat. No. V71-6510, Lot 36408622
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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