Medical and surgical procedure trays recalled for incomplete seal
Stradis Medical recalls medical and surgical procedure trays due to manufacturing defects causing incomplete outer bag seals that may compromise kit sterility.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 for a defect affecting the sterility barrier in surgical procedure trays. No illnesses or injuries have been reported, but the compromised sterility of medical devices used in surgical procedures poses a significant risk of infection if used improperly.
Plain-English summary
Stradis Medical, LLC dba Stradis Healthcare is recalling the Henry Schein Vein Tray (Item No. 570-2738) due to manufacturing conditions that may result in incompletely sealed outer bags.
An incomplete outer bag seal may compromise the sterility of the medical tray kit. If the affected tray is used in medical or surgical procedures without proper sterilization verification, it poses a risk of infection.
The product was distributed nationwide in the United States and Canada. The recall involves 18 units identified by UDI/DI (case) H65857027381, UDI/DI (kit) M75257027380, and Lot/Serial Number 22257490591.
Healthcare facilities and individuals who have the recalled product should stop using it immediately and contact the manufacturer for instructions on return, disposal, or verification of sterilization.
The recalled product
- Product
- HENRY SCHEIN, VEIN TRAY, Item No.570-2738,
- Manufacturer
- Stradis Medical, LLC dba Stradis Healthcare
- Affected units
- 18
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) H65857027381
- UDI/DI (kit)M75257027380
- Serial/Lot Numbers: 22257490591
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 78 recalled by Stradis Medical, LLC dba Stradis Healthcare under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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