FDA Recalls DeRoyal HEART PACK Medical Device Kits
FDA is recalling 51 DeRoyal HEART PACK medical device kits (Lot 57893436) distributed across 23 US states. The specific reason for this Class II recall has not been disclosed.
What this means for you
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: This is a Class II medical device recall with a defined risk of temporary or medically reversible adverse health consequences. Though no illnesses or injuries have been reported and the specific hazard has not been disclosed, Class II recalls represent risk-of-harm products. Per the severity rubric, such products where injury has not yet been reported are classified as High.
Plain-English summary
DeRoyal Industries Inc is recalling 51 units of the DeRoyal HEART PACK medical device, Reference Number 89-8351.13 (Lot 57893436, expiration September 1, 2024). The FDA has classified this as a Class II recall, though the specific reason for the recall has not been disclosed in the available information.
The affected devices were distributed to healthcare facilities in 23 US 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.
The manufacturer initiated this recall voluntarily on November 3, 2022. Notification of affected parties was conducted through multiple channels including email, fax, letter, press release, telephone contact, and facility visits. The recall status remains ongoing.
The recalled product
- Product
- DeRoyal HEART PACK, REF 89-8351.13
- Manufacturer
- DeRoyal Industries Inc
- Category
- Medical Device
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 57893436 exp 9/1/2024
Distribution
Distribution scope not specified by the agency.
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