Dental surgical kits recalled due to incomplete outer bag sealing
Stradis Healthcare is recalling dental surgical procedure kits due to manufacturing issues that may result in incompletely sealed outer bags, potentially compromising kit sterility.
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 for medical devices with a manufacturing defect that may compromise sterility. The potential for contamination in surgical kits represents a significant risk-of-harm scenario.
Plain-English summary
Stradis Medical, LLC dba Stradis Healthcare is recalling STRADIS HEALTHCARE DENTAL CUSTOM PACK (Item No. 41137TDS) due to manufacturing conditions that may result in an incompletely sealed outer bag.
The incompletely sealed bag may breach the sterility of the surgical kit, potentially exposing the contents to contamination. This kit is used in dental and surgical procedures where sterile conditions are essential.
The recall affects 20 units distributed throughout the United States and Canada with lot number 22230489097 (UDI/DI case: M75241137TDS1, kit: M75241137TDS0).
Healthcare providers and patients who have received this product should stop using it immediately and contact Stradis Healthcare for information on replacement or proper disposal.
The recalled product
- Product
- STRADIS HEALTHCARE, DENTAL CUSTOM PACK, Item No.41137TDS,
- Manufacturer
- Stradis Medical, LLC dba Stradis Healthcare
- Hazard
- sterility-breach
- 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 (3)
- UDI/DI (case) M75241137TDS1
- UDI/DI (kit)M75241137TDS0
- Serial/Lot Numbers: 22230489097
Distribution
Distributed nationwide across the United States.
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