Stradis Healthcare catheter angiography kits recalled for defective sterile sealing
Stradis Medical is recalling catheter angiography procedure kits with potentially incompletely sealed outer bags that may compromise the sterile integrity of the medical devices.
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 medical device recall involving a defect that breaches the sterile barrier of surgical procedure kits. While the hazard poses a documented risk of harm, no illnesses or injuries have been reported, placing this at the risk-of-harm level without realized injury.
Plain-English summary
Stradis Medical, LLC, dba Stradis Healthcare, is recalling Henry Schein catheter angiography procedure kits due to a manufacturing defect in the sterile packaging.
The outer bag of the affected kits may be incompletely sealed. An incomplete seal can result in a breach of the sterility assurance of the kit, meaning the internal contents may no longer be guaranteed to be sterile.
The recall affects catheter angiography procedure kits (Item No. 570-2930) distributed nationwide in the United States and in Canada. The affected lot number is 22235490920. A total of 16 units are involved in this recall.
Health care facilities and medical professionals who have received these kits should discontinue use and contact Stradis Healthcare for instructions on return or replacement of the affected kits.
The recalled product
- Product
- HENRY SCHEIN, CATH ANGIO PACK, Item No.570-2930
- Manufacturer
- Stradis Medical, LLC dba Stradis Healthcare
- Hazard
- sterility-breach
- contamination
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) H65857029301
- UDI/DI (kit)M75257029300
- Serial/Lot Numbers: 22235490920
Distribution
Distributed nationwide across the United States.
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