Surgical Procedure Trays Recalled for Potential Sterile Barrier Compromise
Stradis Medical is recalling 104 units of Henry Schein ENT surgical procedure trays due to incomplete sealing of the outer bag, which may compromise the sterility of the kit.
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 an FDA Class II recall of medical devices where the outer sterile barrier may be compromised. No illnesses or injuries have been reported. The hazard is a potential breach of sterility, which poses a risk of harm if contaminated products are used in medical procedures.
Plain-English summary
Stradis Medical, LLC dba Stradis Healthcare is recalling 104 units of Henry Schein ENT Procedure Pack (Item No. 570-2718) distributed in the United States and Canada. The recalled kits carry the following identification: UDI/DI (case) H65857027181, UDI/DI (kit) M75257027180, and Serial/Lot Numbers 22242489582 and 22256491864.
The medical and surgical procedure trays underwent certain manufacturing conditions that resulted in incomplete sealing of the outer bag. This may allow a breach in the sterility of the kit.
Healthcare facilities and practitioners using these trays should cease use and contact Stradis Medical for further instructions. If any products from the recalled lot have been opened or used, facilities should assess the risk and take appropriate corrective action. The FDA is monitoring the situation.
The recalled product
- Product
- HENRY SCHEIN, ENT PACK, Item No.570-2718
- Manufacturer
- Stradis Medical, LLC dba Stradis Healthcare
- Category
- Medical Device — Surgical Trays
- Hazard
- sterile-barrier-compromise
- contamination
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 (4)
- UDI/DI (case) H65857027181
- UDI/DI (kit)M75257027180
- Serial/Lot Numbers: 22242489582
- 22256491864
Distribution
Distributed nationwide across the United States.
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