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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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
- Affected units
- 48
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
Part of a larger recall action
This product is one of 156 recalled by DeRoyal Industries Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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