DeRoyal SafeLiner Suction Canister Kit Recalled for Insufficient Seal
DeRoyal Industries is recalling 5,112 units of SafeLiner Suction Canister Kits due to an insufficient seal under low or intermittent suction conditions.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a functional defect in a medical device that poses a risk of harm, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
DeRoyal Industries Inc is recalling 5,112 units of DeRoyal(R) SafeLiner Suction Canister Kits, Semi-Rigid, 1000cc, REF 71-6518, Non-Sterile. The affected product is identified by Lot 364817213. These medical devices are prescription-only and intended for general hospital use.
The recall was initiated because the suction canisters and lids have an insufficient seal under low or intermittent suction conditions. This defect may compromise the device's ability to maintain proper suction levels.
The product was distributed nationwide, including in Michigan, Ohio, Indiana, Florida, West Virginia, Virginia, North Carolina, and New York. Healthcare facilities and consumers who have this specific lot of suction canister kits should stop using them and contact DeRoyal Industries Inc for instructions on return or replacement.
The recalled product
- Product
- DeRoyal(R) SafeLiner Suction Canister Kit, SEMI-RIGID, 1000cc, REF 71-6518, NON-STERILE, Rx Only, general hospital
- Manufacturer
- DeRoyal Industries Inc
- Affected units
- 5,112
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot 364817213
Distribution
Part of a larger recall action
This product is one of 2 recalled by DeRoyal Industries Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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