The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0610-2023·Announced 2022-12-21

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.

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: 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
Affected units
51

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

Distributed in 23 states:

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.

See all 156 products in this recall →

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