DeRoyal Cardiac Hypothermia Tray Recalled Due to Contaminated Irrigation Sets
DeRoyal is recalling Cardiac Hypothermia Trays because they contained irrigation sets previously recalled by Hospira.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any hospitalizations, injuries, or specific high-risk pathogens, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
DeRoyal Industries, Inc. is recalling DeRoyal Cardiac Hypothermia Trays, reference number 50-9422.07. The recall involves 230 units distributed in Michigan, Georgia, Ohio, Illinois, Missouri, and Indiana. The affected lot numbers are 30375680, 30515347, 30927691, 32922641, and 33656541.
The recall was initiated because the surgical kits contained irrigation sets that were subsequently recalled by Hospira. The source text does not specify the exact nature of the defect or hazard associated with the Hospira recall, nor does it report any illnesses or injuries.
Healthcare facilities and consumers should stop using these trays and contact DeRoyal Industries, Inc. for instructions on return or replacement.
The recalled product
- Product
- DeRoyal Cardiac Hypothermia Tray, REF 50-9422.07, 1 Per Pack, Distributed by: DeRoyal Industries, Inc.; Made in Guatemala
- Manufacturer
- DeRoyal Industries Inc
- Category
- Medical Device — Surgical Kits
- Hazard
- Affected units
- 230
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 (5)
- Lot Numbers: 30375680
- 30515347
- 30927691
- 32922641
- 33656541
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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