DeRoyal Cardiac Linen Pack Recalled, 204 Kits Affected
DeRoyal Industries initiated an ongoing voluntary Class II recall of 204 kits of the DeRoyal CARDIAC LINEN PACK distributed to 23 U.S. states.
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: This is a voluntary Class II medical device recall with no reported illnesses, injuries, or deaths. Per the severity rubric, voluntary precautionary recalls without reported harm are classified as Moderate.
Plain-English summary
DeRoyal Industries Inc. has initiated a voluntary Class II recall of the DeRoyal CARDIAC LINEN PACK (Reference 89-10543.02). The recall affects 204 kits that have been distributed across 23 U.S. states including Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, and Mississippi.
The affected product lots are: - Lot 56336988 (expires November 1, 2023) - Lot 57188770 (expires August 1, 2024) - Lot 57393440 (expires May 1, 2024) - Lot 57644325 (expires July 1, 2024)
The recall is classified as ongoing. Healthcare facilities and consumers with this product should verify their lot numbers against the list above and contact DeRoyal Industries Inc. for further instructions.
The recalled product
- Product
- DeRoyal CARDIAC LINEN PACK, REF 89-10543.02
- Manufacturer
- DeRoyal Industries Inc
- Category
- Medical Device — Hospital Linens
- Affected units
- 204
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 (4)
- Lot Numbers: Lot 56336988 exp 11/1/2023
- Lot 57188770 exp 8/1/2024
- Lot 57393440 exp 5/1/2024
- Lot 57644325 exp 7/1/2024
Distribution
Part of a larger recall action
This product is one of 156 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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