Surgical Procedure Trays with Potentially Compromised Sterile Packaging
Stradis Healthcare is recalling surgical procedure trays due to potentially incomplete outer bag sealing that may compromise 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 FDA Class II recall involves a surgical device with potential sterility compromise. While no illnesses or injuries have been reported, this is a risk-of-harm product where sterility breach could allow contamination of surgical instruments, meeting the High severity criterion.
Plain-English summary
Stradis Healthcare is recalling STRADIS HEALTHCARE Phleb surgical procedure trays and kits (Item No. 682-1425) because the outer bag may be incompletely sealed due to certain manufacturing conditions. This incomplete sealing could result in a breach in the sterility of the kit.
The recalled trays and kits were distributed nationwide in the United States and Canada. The affected lot number is 22236490624, and the recall involves 20 units.
A breach in sterility could allow exposure of the medical instruments and materials to contamination. These are surgical procedure kits intended for medical use.
The recalled product
- Product
- STRADIS HEALTHCARE, Phleb, Item No.682-1425,
- Manufacturer
- Stradis Medical, LLC dba Stradis Healthcare
- Affected units
- 20
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) M75268214251
- UDI/DI (kit)M75268214250
- Serial/Lot Numbers: 22236490624
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 78 recalled by Stradis Medical, LLC dba Stradis Healthcare under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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