Medical Trays Recalled for Potentially Compromised Sterility from Incomplete Sealing
Stradis Medical is recalling 800 units of HENRY SCHEIN Vein Clinics 1 surgical trays because the outer bag may be incompletely sealed, potentially compromising sterility. No infections have been reported.
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 recall for a manufacturing defect affecting a critical product attribute (sterility) used in invasive surgical procedures. No hospitalizations or reported illnesses, but sterility compromise represents a risk-of-harm scenario where injury has not yet been reported.
Plain-English summary
Stradis Medical, LLC is recalling approximately 800 units of HENRY SCHEIN Vein Clinics 1 (Item No. 570-1426) surgical procedure trays and kits due to a manufacturing defect.
During manufacturing, the outer bag of the trays may be incompletely sealed. This incomplete seal may result in a breach of the sterility assurance of the kit, which is essential for safe use in surgical procedures.
The affected product was distributed nationwide in the United States and Canada. The recall affects trays with Lot/Serial Number 22257490682. To date, no infections or illnesses related to this defect have been reported.
Patients and healthcare providers who have received these trays should contact their healthcare facility or manufacturer for information about product replacement or return.
The recalled product
- Product
- HENRY SCHEIN, Vein Clinics 1, Item No.570-1426
- Manufacturer
- Stradis Medical, LLC dba Stradis Healthcare
- Hazard
- sterility-breach
- contamination-risk
- seal-failure
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) H65857014261
- UDI/DI (kit)M75257014260
- Serial/Lot Numbers: 22257490682
Distribution
Distributed nationwide across the United States.
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