The Recall Desk
ModerateFDA (Devices)·Z-0572-2023·Announced 2022-12-21

DeRoyal ophthalmology procedure packs recalled for defective 3M surgical drapes

DeRoyal's GEO-MED ophthalmology procedure packs containing recalled 3M Health Care Steri Drapes are being recalled. Thirty kits were distributed across 23 US 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 described in the source document. The specific hazard is not detailed; this appears to be a consequential recall due to the inclusion of separately recalled components.

Plain-English summary

DeRoyal Industries Inc. has recalled 30 GEO-MED OPHTHALMOLOGY CUSTOM PACK kits (reference 89-6387.09, Lot 57709678, expiring 10/1/2024). These procedure packs contain 3M Health Care Steri Drapes that have been subject to a separate product recall.

The specific reason for the 3M drape recall is not specified in this notice.

The affected kits were distributed to healthcare facilities 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 recalled product

Product
GEO-MED OPTHALMOLOGY CSTM PCK, REF 89-6387.09
Manufacturer
DeRoyal Industries Inc
Category
Medical Device — Surgical supplies / Procedure packs
Hazard
  • product-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 57709678 exp 10/1/2024

Distribution

Distribution scope not specified by the agency.

Related recalls

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