DeRoyal Shoulder Arthroscopy Procedure Packs Recalled Due to Defective Surgical Drapes
DeRoyal is recalling 144 shoulder arthroscopy procedure packs that contain recalled 3M Health Care Steri Drapes. The packs were distributed 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: FDA Class II medical device recall of surgical equipment used in sterile surgical procedures. While no illnesses or injuries have been reported, surgical procedure packs represent inherent risk-of-harm products, meeting the High severity threshold for products where injury has not yet been reported.
Plain-English summary
DeRoyal Industries Inc. is recalling 144 shoulder arthroscopy procedure packs (model RF, reference 89-6628.09). The packs are recalled because they contain 3M Health Care Steri Drapes that are the subject of an FDA recall by the manufacturer.
The affected lot numbers are Lot 56391741 (expiration 1/1/2023), Lot 56617587 (expiration 2/1/2025), and Lot 57391604 (expiration 1/1/2024). These procedure packs were distributed to healthcare facilities in 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.
Customers and healthcare facilities that have received these procedure packs should not use them and should contact DeRoyal Industries Inc. for instructions on returning or replacing the recalled product.
The recalled product
- Product
- DeRoyal SHOULDER ARTHORSCOPY PACK RF, REF 89-6628.09
- Manufacturer
- DeRoyal Industries Inc
- Hazard
- surgical-drape-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 56391741 exp 1/1/2023
- Lot 56617587 exp 2/1/2025
- Lot 57391604 exp 1/1/2024
Distribution
Distribution scope not specified by the agency.
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