DeRoyal Cataract Procedure Packs Recalled Due to Defective Sterile Drapes
DeRoyal Industries is recalling approximately 1,220 cataract procedure packs that contain recalled 3M Health Care Steri Drapes. The affected kits were distributed to healthcare facilities across 23 U.S. 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: This is a Class II medical device recall involving surgical procedure packs. While no illnesses or injuries are reported in this notice, the product is used in surgical procedures where a defective component could pose a risk.
Plain-English summary
DeRoyal Industries Inc. is recalling its CATARACT PACK CSM (REF 89-6863), a procedure kit used in cataract surgical procedures. The recall is due to the inclusion of 3M Health Care Steri Drapes that have been previously recalled by the FDA.
Approximately 1,220 kits were distributed to healthcare facilities across 23 U.S. 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. Specific affected lot numbers include Lot 55807995 (expiration date January 1, 2023) and additional lots 56029890, 57001098, 57198118, and 56613261 (expiration dates not provided in this notice).
The FDA classified this as a Class II recall.
The recalled product
- Product
- DeRoyal CATARACT PACK CSM, REF 89-6863
- Manufacturer
- DeRoyal Industries Inc
- Hazard
- defective-component
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 (5)
- Lot Numbers: Lot 55807995 exp 1/1/2023
- lot 56029890 exp ***
- lot 57001098 exp ***
- lot 57198118 exp ***
- lot 56613261 exp ***
Distribution
Distribution scope not specified by the agency.
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