Stradis Healthcare Surgical Pack Recall for Compromised Sterility
Stradis Healthcare is recalling surgical kits because the outer bag may be incompletely sealed, potentially compromising the sterility of the product.
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 involving a theoretical risk of sterility breach and potential contamination with no reported illnesses or injuries. The incomplete outer bag seal presents a risk of harm to patients where injury has not yet been reported, meeting the High severity threshold.
Plain-English summary
Stradis Medical, LLC, doing business as Stradis Healthcare, is recalling STRADIS HEALTHCARE Surg Pack (Item No. 40450SMS), a dental surgical procedure kit. The recall was initiated because certain kits underwent manufacturing conditions that may result in an incompletely sealed outer bag.
An incompletely sealed outer bag may result in a breach of the kit's sterility. Compromised sterility could allow contamination that would expose patients to infection risk during surgical procedures.
The affected kits were distributed nationwide in the United States and Canada. Affected units are identified by UDI/DI (case) M75240450SMS1, UDI/DI (kit) M75240450SMS0, and Lot Number 22262490676. Stradis Healthcare advises healthcare facilities to review their inventory and quarantine any affected kits. Consumers should contact Stradis Healthcare or their healthcare provider if they have questions about this recall.
The recalled product
- Product
- STRADIS HEALTHCARE, Surg Pack, Item No.40450SMS, dental
- 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) M75240450SMS1
- UDI/DI (kit)M75240450SMS0
- Serial/Lot Numbers: 22262490676
Distribution
Distributed nationwide across the United States.
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