The Recall Desk
ModerateFDA (Devices)·Z-0602-2023·Announced 2022-12-21

DeRoyal Endovenous Procedure Packs Recalled Due to Affected Steri Drapes

DeRoyal is recalling 88 endovenous procedure packs containing 3M Health Care Steri Drapes that have been recalled. The packs were distributed across 23 US states; consumers should stop using them immediately.

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: FDA Class II medical device recall with no reported illnesses, injuries, or deaths. The source does not specify the nature of the defect in the Steri Drapes, indicating a precautionary secondary recall.

Plain-English summary

DeRoyal Industries Inc is recalling 88 endovenous procedure packs (model ENDOVENOUS PACK, REF 89-7762.05) because they contain 3M Health Care Steri Drapes that have been recalled.

The affected lots are: Lot 54880154 (expiration 12/1/2023) and Lot 57186299 (expiration 10/1/2024). The packs were distributed to medical facilities in 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.

Consumers who have received these procedure packs should stop using them immediately. Contact DeRoyal Industries Inc for instructions on how to handle the affected product.

The recalled product

Product
DeRoyal ENDOVENOUS PACK, REF 89-7762.05
Manufacturer
DeRoyal Industries Inc
Category
Medical Device — Surgical Procedure Packs
Hazard
  • device-defect

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 (2)

  • Lot Numbers: Lot 54880154 exp 12/1/2023
  • Lot 57186299 exp 10/1/2024

Distribution

Distribution scope not specified by the agency.

Related recalls

Same category