The Recall Desk
ModerateFDA (Devices)·Z-0604-2023·Announced 2022-12-21

GEO-MED Lower Extremity Procedure Packs Recalled Due to Defective 3M Steri Drapes

DeRoyal Industries is recalling 48 kits of GEO-MED Lower Extremity Packs because they contain 3M Health Care Steri Drapes that have been recalled. The affected kits were distributed to healthcare facilities across the United 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 a Class II medical device recall with no reported illnesses or injuries. It is a secondary recall initiated because the product contains separately recalled 3M components. Without reported harm, the hazard is best characterized as a precautionary measure, consistent with a Moderate severity rating.

Plain-English summary

DeRoyal Industries Inc is recalling 48 kits of GEO-MED Lower Extremity Packs (Reference 89-8252.02) because they contain 3M Health Care Steri Drapes that are subject to a separate FDA recall.

The affected packs were distributed to healthcare facilities in 23 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 numbers are Lot 56440662 (expiration October 1, 2024) and Lot 56618491 (expiration November 1, 2024).

Healthcare facilities in possession of these packs should cease using them and contact DeRoyal Industries Inc regarding the recall.

The recalled product

Product
GEO-MED LOWER EXTERMITY PACK, REF 89-8252.02
Manufacturer
DeRoyal Industries Inc
Hazard
  • device-defect
  • sterility-risk

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 56440662 exp 10/1/2024
  • Lot 56618491 exp 11/1/2024

Distribution

Distribution scope not specified by the agency.