STRADIS HEALTHCARE Surgical Procedure Trays Recalled for Incomplete Sterile Sealing
STRADIS HEALTHCARE surgical procedure trays and kits are being recalled due to a manufacturing condition that may result in incomplete sealing of the outer bag, 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 a Class II medical device recall for a potential sterility breach. Although the hazard is theoretical in nature, incomplete sealing of medical procedure trays poses a significant risk of patient harm through contamination, qualifying as a risk-of-harm product.
Plain-English summary
STRADIS HEALTHCARE is recalling medical and surgical procedure trays and kits (Item No. 686-142, Lot 22236491028) distributed in the United States and Canada. The recall is due to a manufacturing condition that may result in incomplete sealing of the outer bag.
The incomplete sealing may result in a breach of the kit's sterility. Patients undergoing medical or surgical procedures with these kits could potentially be exposed to contamination.
This is an FDA Class II medical device recall.
The recalled product
- Product
- STRADIS HEALTHCARE, Femoral, Vasc, Item No.686-142,
- Manufacturer
- Stradis Medical, LLC dba Stradis Healthcare
- Affected units
- 10
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) M7526861421
- UDI/DI (kit)M7526861420
- Serial/Lot Numbers: 22236491028
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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