Angio Pack surgical trays recalled for incomplete sealing and sterility breach
Stradis Healthcare is recalling Angio Pack surgical trays due to manufacturing defects that may leave the outer bag incompletely sealed, compromising product sterility. Affected units were distributed nationwide in the US and Canada.
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 of a sterile medical device where manufacturing defects may compromise product sterility. No illnesses, injuries, or deaths have been reported. The hazard represents a risk to patient safety if sterile integrity is lost, meeting the criterion for High severity as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Stradis Healthcare is recalling Angio Pack surgical procedure trays (Item No. 686-199, lot number 22236491017) due to manufacturing defects. The outer bag of the tray may be incompletely sealed, which could compromise the sterility of the kit—a critical requirement for safe use in medical and surgical procedures.
The affected Angio Packs were distributed nationwide in the United States and Canada. The recall involves units with UDI codes M7526861991 (case) and M7526861990 (kit). No illnesses or injuries have been reported to date.
The recalled product
- Product
- STRADIS HEALTHCARE, Angio Pack, Item No.686-199,
- Manufacturer
- Stradis Medical, LLC dba Stradis Healthcare
- Hazard
- sterility-breach
- incomplete-seal
- 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) M7526861991
- UDI/DI (kit)M7526861990
- Serial/Lot Numbers: 22236491017
Distribution
Distributed nationwide across the United States.
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