DeRoyal Surgical Procedure Packs Recalled for Defective Sterile Drapes
DeRoyal Industries is recalling 135 surgical procedure kits containing recalled 3M Health Care Steri Drapes. The affected kits were distributed to 23 U.S. 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: Class II FDA recall with no reported illnesses, injuries, or deaths. This represents a precautionary action due to inclusion of previously recalled supplier components.
Plain-English summary
DeRoyal Industries Inc. is recalling 135 units of GEO-MED SHOULDER ARTHROSCOPY KNEE PACK (Reference 89-5797.09) that contain recalled 3M Health Care Steri Drapes. The affected kits were distributed across 23 states including 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 three affected lot numbers are: Lot 56392226 (expiration 9/1/2023), Lot 56683525 (expiration 9/1/2023), and Lot 57001506 (expiration 4/1/2024).
This recall is issued due to the inclusion of defective Steri Drapes previously recalled by 3M Health Care. Patients and healthcare facilities should discontinue use of affected procedure packs immediately and contact DeRoyal Industries Inc. for instructions regarding replacement or return.
The recalled product
- Product
- GEO-MED SHOULDER ARTHROSCOPY KNEE PACK, REF 89-5797.09
- Manufacturer
- DeRoyal Industries Inc
- Hazard
- Affected units
- 135
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 (3)
- Lot Numbers: Lot 56392226 exp 9/1/2023
- Lot 56683525 exp 9/1/2023
- Lot 57001506 exp 4/1/2024
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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