DeRoyal Total Knee Procedure Pack Recalled for Defective Steri Drapes
DeRoyal Industries is recalling 79 units of GEO-MED TOTAL KNEE PACK A & B due to defective 3M Steri Drapes included in the procedure packs. The affected units were distributed across 23 states.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II classification for medical devices used in surgical procedures. No reported illnesses or injuries, but the device classification and surgical application context warrant elevated severity.
Plain-English summary
DeRoyal Industries Inc is recalling 79 units of GEO-MED TOTAL KNEE PACK A & B PGYK (Reference 89-5796.13) because the procedure packs contain defective 3M Health Care Steri Drapes that have been subject to recall. These sterile barrier drapes are included in knee surgery procedure packs.
The affected units include three lot numbers: Lot 56184443 (expiration 5/1/2023), Lot 56618408 (expiration 1/1/2023), and Lot 57589531 (expiration 12/1/2023). The procedure packs were distributed across 23 U.S. 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.
This is an FDA Class II recall. Facilities that received these procedure packs should identify and set aside units matching the affected lot numbers.
The recalled product
- Product
- GEO-MED TOTAL KNEE PACK A & B PGYK, REF 89-5796.13
- Manufacturer
- DeRoyal Industries Inc
- Hazard
- sterile-barrier-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 (3)
- Lot Numbers: Lot 56184443 exp 5/1/2023
- Lot 56618408 exp 1/1/2023
- Lot 57589531 exp 12/1/2023
Distribution
Distribution scope not specified by the agency.
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