Reported Oct 29, 2014 · Terminated
Suction canisters labels as follows: 1) DeRoyal(R) SUCTION CANISTER, 1000cc, SEMI-RIGID, REF 71-6510, NON-STERILE, Rx…
DeRoyal Industries Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: DeRoyal Industries Inc · 200 Debusk Ln · Powell, TN · 37849-4703
Is this the product you have?
- Suction canisters labels as follows1) 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
- Lot codes and dates
- 1) DeRoyal(R), REF 71-6510, Lot 36408631 2) NOVAPLUS(TM) Cat. No. V71-6510, Lot 36408622
- Amount recalled
- 13,900 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
These lots of suction canisters and lids have an insufficient seal under low or intermittent suction condition.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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