Medical device heart pack kit recalled by DeRoyal Industries
DeRoyal Industries is recalling 240 DeRoyal HEART PACK medical device kits (REF 89-8351.11). The specific reason for the recall is not disclosed in the FDA notice.
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, firm-initiated Class II medical device recall with no reported adverse events. Per the severity rubric, voluntary precautionary recalls are classified as Moderate.
Plain-English summary
DeRoyal Industries Inc is conducting a voluntary firm-initiated recall of 240 DeRoyal HEART PACK kits, model REF 89-8351.11. The affected lot numbers are 56189105 and 57005558, both with an expiration date of September 1, 2024.
The FDA recall notice does not specify the reason for the recall. This is classified as a Class II medical device recall.
The affected kits were distributed across 23 U.S. states: 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.
Consumers and healthcare facilities in possession of affected kits should contact DeRoyal Industries Inc for instructions on how to proceed.
The recalled product
- Product
- DeRoyal HEART PACK, REF 89-8351.11
- Manufacturer
- DeRoyal Industries Inc
- Category
- Medical Device
- Affected units
- 240
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 (2)
- Lot Numbers: Lot 56189105 exp 9/1/2024
- Lot 57005558 exp 9/1/2024
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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