The Recall Desk
ModerateFDA (Devices)·Z-0563-2023·Announced 2022-12-21

DeRoyal Extremity Trays Recalled Due to Affected 3M Steri Drapes

DeRoyal is recalling its EXTREMITY TRAY procedure packs because they contain recalled 3M Health Care Steri Drapes. The affected kits are distributed across multiple 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: FDA Class II classification for a medical device recall with no reported illnesses or injuries in the source material. This is a precautionary recall due to affected components from a supplier.

Plain-English summary

DeRoyal Industries Inc is recalling DeRoyal EXTREMITY TRAY PGYBK procedure packs (Reference 89-4081.07) because they contain 3M Health Care Steri Drapes that have been recalled.

The recall affects 130 kits distributed to healthcare facilities in 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 affected lots are Lot 56394918 (expiration 11/3/2024) and Lot 56778591 (expiration 12/1/2024).

Healthcare facilities should check their inventory using the lot numbers provided and contact DeRoyal Industries Inc for further guidance.

The recalled product

Product
DeRoyal EXTREMITY TRAY PGYBK, REF 89-4081.07
Manufacturer
DeRoyal Industries Inc
Category
Medical Device — Surgical / Procedure Packs
Hazard
  • defective-component

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 56394918 exp 11/3/2024
  • Lot 56778591 exp 12/1/2024

Distribution

Distribution scope not specified by the agency.

Related recalls

Same category