The Recall Desk
ModerateFDA (Devices)·Z-0648-2023·Announced 2022-12-21

DeRoyal Myelogram Packs Recalled for Inclusion of Defective 3M Drapes

DeRoyal Industries is recalling 480 myelogram procedure packs because they contain 3M Steri Drapes that have been recalled. These packs were distributed to medical facilities in 23 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 an FDA Class II recall with no reported illnesses or injuries. The hazard is the inclusion of already-recalled 3M sterilization drapes in myelogram procedure packs. With no evidence of patient harm and a precautionary recall approach, this scores as Moderate.

Plain-English summary

DeRoyal Industries Inc is recalling 480 myelogram procedure packs (Model REF 89-9304.06, Lot 57913388, expiring 12/1/2026) because they contain 3M Health Care Steri Drapes that have been recalled.

The affected packs were distributed across 23 US 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 is being conducted at the manufacturer level. Medical facilities with affected packs should verify their inventory using the provided lot number.

The recalled product

Product
DeRoyal MYELOGRAM PACK, REF 89-9304.06
Manufacturer
DeRoyal Industries Inc
Category
Medical Device — Medical Procedure Packs
Hazard
  • component-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 (1)

  • Lot Numbers: Lot 57913388 exp 12/1/2026

Distribution

Distribution scope not specified by the agency.

Related recalls

Same category