DeRoyal HEART PACK procedure kits recalled for defective component
DeRoyal Industries is recalling 102 HEART PACK procedure kits (Lot 57367401, expiration 3/1/2025) distributed across 23 U.S. states because they contain recalled 3M Health Care Steri Drapes.
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 medical device recall without reported illnesses or injuries; involves a recalled component representing a risk-of-harm product where injury has not yet been reported.
Plain-English summary
DeRoyal Industries Inc is recalling HEART PACK procedure kits (Reference 89-8351.12, Lot 57367401, expiration date March 1, 2025). The recall involves 102 kits.
These procedure packs are being recalled because they contain 3M Health Care Steri Drapes that have been recalled by the FDA. The specific defect or hazard associated with the Steri Drapes component is not specified in the available notice.
The recalled kits were distributed to healthcare facilities 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 recalled product
- Product
- DeRoyal HEART PACK, REF 89-8351.12
- Manufacturer
- DeRoyal Industries Inc
- Hazard
- Affected units
- 102
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 Numbers: Lot 57367401 exp 3/1/2025
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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