Surgical procedure trays recalled for incomplete outer-bag sealing
Stradis Healthcare is recalling surgical procedure trays and kits due to manufacturing defects that may result in incomplete sealing of the outer bag, potentially compromising sterility. Affected products 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: FDA Class II recall for a medical device with potential for sterility breach due to incomplete outer-bag sealing. The theoretical nature of the hazard (incomplete seal may result in contamination, but no contamination confirmed) places this at the High level per the rubric.
Plain-English summary
Stradis Medical, LLC dba Stradis Healthcare is recalling STRADIS HEALTHCARE Vein surgical procedure trays and kits (Item No. 682-1732) due to a manufacturing defect. Certain manufacturing conditions may result in the outer bag being incompletely sealed, which may result in a breach of the kit's sterility.
The affected products were distributed nationwide in the United States and Canada. The implicated lot number is 22230489185, with UDI/DI codes M75268217321 (case) and M75268217320 (kit).
Since an unsealed or improperly sealed outer bag may allow contamination of the sterile contents, facilities that have received these kits should verify they do not use affected lots. The FDA classified this as a Class II recall.
The recalled product
- Product
- STRADIS HEALTHCARE, Vein, Item No.682-1732,
- 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) M75268217321
- UDI/DI (kit)M75268217320
- Serial/Lot Numbers: 22230489185
Distribution
Distributed nationwide across the United States.
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