Surgical procedure kit recalled due to incompletely sealed outer bag
A HENRY SCHEIN extremity pack surgical kit is being recalled because its outer bag may not be completely sealed, which could compromise the sterility of the kit. Affected units were distributed nationwide in the US and Canada.
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 medical device recall involving a sterility breach in surgical procedure trays—a risk-of-harm product used in invasive procedures. Although no illnesses or injuries have been reported, the potential for contamination during surgery represents a significant patient safety risk.
Plain-English summary
Stradis Medical, LLC dba Stradis Healthcare is recalling HENRY SCHEIN EXTREMITY PACK surgical procedure trays and kits (Item No. 570-2946) due to a manufacturing defect. The outer bags of these kits may be incompletely sealed, which could result in a breach of the kit's sterility.
Sterile surgical procedure trays are intended to maintain the cleanliness and safety of medical instruments and materials used during procedures. If the outer bag seal is compromised, the kit may no longer be sterile and could pose a contamination risk during surgery or medical procedures.
The recall affects 144 units distributed nationwide in the United States and Canada. The affected lot is identified by Serial/Lot Number 22242490745. Facilities and medical providers who have received this product should contact the manufacturer or the FDA for further guidance on affected units and appropriate corrective actions.
The recalled product
- Product
- HENRY SCHEIN, EXTREMITY PACK, Item No.570-2946
- Manufacturer
- Stradis Medical, LLC dba Stradis Healthcare
- Hazard
- sterility-breach
- contamination-risk
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)
- UDI/DI (case) H65857029461
- UDI/DI (kit)M75257029460
- Serial/Lot Numbers: 22242490745
Distribution
Distributed nationwide across the United States.
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