DeRoyal Suction Connector Tubing Recalled for Assembly and Function Issues
DeRoyal suction connector tubing in five U.S. states has been recalled because the connector's inner diameter is smaller than the suction canister lid port, making assembly difficult and risking inadequate suction and delayed patient care.
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: FDA Class II recall for suction connector tubing with a design flaw that could cause inadequate suction and patient care delays. This is classified as High severity as a risk-of-harm product where no injuries or illnesses have been reported.
Plain-English summary
DeRoyal Industries Inc is recalling three models of suction connector tubing: REF 71-C5100NS, REF 71-C6100NS, and REF 71-C7100NS. The products have been distributed in Illinois, Minnesota, North Carolina, Pennsylvania, and Virginia, affecting approximately 714 cases.
These tubing connectors are intended for fluid movement and are designed to attach to suction canister lids. The inner diameter of the connector tubing is smaller than the port connection on the suction canister lid. Combined with the durometer (hardness) of the plastic material, this size mismatch makes the assembly difficult.
When the connector does not assemble properly, it may result in inadequate suction, potentially causing delays in patient care. This is a Class II medical device recall.
The recalled product
- Product
- DeRoyal REF 71-C5100NS Tubing, Suction, Connector; DeRoyal REF 71-C6100NS Tubing, Suction, Connector; DeRoyal REF 71-C7100NS Tubing, Suction, Connector Indicated use - Fluid Movement
- Manufacturer
- DeRoyal Industries Inc
- Affected units
- 714
Distribution
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