The Recall Desk
ModerateFDA (Devices)·Z-0615-2023·Announced 2022-12-21

DeRoyal SPINE PACK procedure kits recalled due to recalled Steri Drapes

DeRoyal SPINE PACK kits have been recalled because they contain 3M Health Care Steri Drapes components that have been previously recalled. Affected units should not be used.

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 an FDA Class II recall without reported illnesses or injuries. The recall is precautionary in nature, initiated because the product contains a component that has been separately recalled.

Plain-English summary

DeRoyal SPINE PACK procedure kits (reference number 89-8361.10) have been recalled due to the inclusion of 3M Health Care Steri Drapes components that have been previously recalled.

Approximately 96 kits were distributed to healthcare facilities 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 affected lot is Lot 57745943, which has an expiration date of December 1, 2026.

Healthcare facilities and practitioners with this product should discontinue use immediately. Contact DeRoyal Industries Inc for information regarding the return or replacement of affected procedure packs.

The recalled product

Product
DeRoyal SPINE PACK, REF 89-8361.10
Manufacturer
DeRoyal Industries Inc
Category
Medical Device — Surgical Procedure Pack
Hazard
  • recalled-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 (1)

  • Lot Numbers: Lot 57745943 exp 12/1/2026

Distribution

Distribution scope not specified by the agency.

Related recalls

Same category