DeRoyal Heart Tracecart Recall Due to Sterile Component Packaging Issue
DeRoyal is recalling Heart Tracecarts because they contain a sterile chest drainage product affected by a packaging configuration issue.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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: The recall is classified as FDA Class III, which is defined as unlikely to cause adverse health consequences. The hazard is related to packaging configuration of a contained component, with no reported injuries or illnesses in the source text.
Plain-English summary
DeRoyal Industries Inc is recalling SRHS DeRoyal Heart Tracecarts (REF 53-1913). These are prescription-only, non-sterile products that contain a sterile Maquet Getinge Group chest drainage product. The recall is being conducted because the contained sterile product was previously recalled due to the current packaging configuration of the Atrium Ocean, Oasis, Express, and Express Mini chest drainage products.
The recall affects 1,157 units distributed in Mississippi and Louisiana. The source text does not specify the exact lot numbers, dates, or specific consumer actions required beyond the recall notice itself.
The recalled product
- Product
- SRHS DeRoyal Heart Tracecart REF 53-1913, Rx Only, NON-STERILE PRODUCT CONTAINED WITHIN.
- Manufacturer
- DeRoyal Industries Inc
- Hazard
- Affected units
- 1,157
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 (20)
- Lot Numbers: 27273826
- 27324507
- 27388691
- 27453704
- 27567701
- 27760202
- 27784829
- 27883843
- 27883851
- 27915382
- 27970710
- 28013209
- 28103933
- 28117702
- 28158889
- 28158897
- 28373571
- 28506329
- 28550670
- 28678471
Distribution
Part of a larger recall action
This product is one of 2 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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