Medical device recall for DeRoyal TRANS CANAL PACK units
DeRoyal Industries Inc is voluntarily recalling 156 kits of the TRANS CANAL PACK medical device distributed across 23 U.S. states.
What this means for you
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 Class II voluntary recall initiated by the firm with no reported illnesses, injuries, or fatalities. The specific hazard is not stated in the source material. Voluntary precautionary recalls without documented harm are classified as Moderate per the rubric.
Plain-English summary
DeRoyal Industries Inc is voluntarily recalling 156 kits of the DeRoyal TRANS CANAL PACK (Reference 89-7157.12), a medical device classified as Class II by the FDA.
The specific reason for this recall is not stated in the available source material. The affected lots are: Lot 57029630 (expiration 8/1/2024), Lot 57387111 (expiration 6/1/2026), and Lot 57894800 (expiration date not specified).
The recalled units 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. The recall was initiated on November 3, 2022, and remains ongoing.
Consumers and healthcare facilities with possession of affected units should contact DeRoyal Industries Inc for further instructions regarding the recall.
The recalled product
- Product
- DeRoyal TRANS CANAL PACK, REF 89-7157.12
- 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 (3)
- Lot Numbers: Lot 57029630 exp 8/1/2024
- Lot 57387111 exp 6/1/2026
- Lot 57894800 exp ***
Distribution
Distribution scope not specified by the agency.
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