Stradis Healthcare Thoracic Surgery Kits Recalled for Sterility Risk
Thoracic Phleb procedure kits from Stradis Healthcare are being recalled due to incomplete outer bag sealing during manufacturing, which may compromise 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 involving surgical procedure kits where a manufacturing defect (incomplete bag sealing) poses a risk to patient safety through potential sterility breach. No injuries or illnesses have been reported to date, placing this within the 'risk-of-harm products where injury has not yet been reported' criterion.
Plain-English summary
Stradis Medical, LLC dba Stradis Healthcare is recalling STRADIS HEALTHCARE Thoracic Phleb surgical procedure kits (Item No. 682-1228). The affected kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may compromise the sterility of the surgical kits.
The recall affects 5 units that were distributed nationwide in the United States and Canada. The affected product can be identified by the following identifiers: UDI/DI (case) M7268212281, UDI/DI (kit) M7268212280, and Serial/Lot Number 22237491041.
The recalled product
- Product
- STRADIS HEALTHCARE, Thoracic Phleb, Item No.682-1228,
- Manufacturer
- Stradis Medical, LLC dba Stradis Healthcare
- Affected units
- 5
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) M7268212281
- UDI/DI (kit)M7268212280
- Serial/Lot Numbers: 22237491041
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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