HENRY SCHEIN Amnio Trays Recalled for Incomplete Outer Bag Seal
HENRY SCHEIN Amnio Trays (Item No. 570-3059) manufactured by Stradis Medical are being recalled because the outer bag may be incompletely sealed, potentially compromising the sterility of the medical 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: FDA Class II medical device with potential sterility compromise through incomplete outer bag seal. Sterile medical procedure trays are risk-of-harm products where contamination could lead to infection or other serious complications. No illnesses or injuries have been reported.
Plain-English summary
Stradis Medical, LLC dba Stradis Healthcare is recalling HENRY SCHEIN Amnio Trays (Item No. 570-3059) due to a manufacturing defect. Approximately 510 units were distributed nationwide in the United States and Canada.
The outer bag of these medical procedure kits may be incompletely sealed, potentially compromising the sterility of the kit. An incomplete seal creates a risk that the contents may become contaminated or exposed.
The affected trays are identified by UDI/DI (case) H65857030591, UDI/DI (kit) M75257030590, and Serial/Lot Number 22257487536.
Healthcare providers, facilities, and anyone who received these amnio trays should cease using them immediately and contact Stradis Medical, LLC dba Stradis Healthcare for replacement or return instructions.
The recalled product
- Product
- HENRY SCHEIN, Amnio Tray, Item No.570-3059,
- Manufacturer
- Stradis Medical, LLC dba Stradis Healthcare
- Hazard
- incomplete-seal
- sterility-breach
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) H65857030591
- UDI/DI (kit)M75257030590
- Serial/Lot Numbers: 22257487536
Distribution
Distributed nationwide across the United States.
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