Cordis Cardiac Catheter Sets Distributed Non-Sterile, Labeled Sterile
Cordis US Corp is recalling cardiac catheter sets (Lot 18223410) distributed in Oklahoma. The devices were non-sterile but labeled as sterile, creating infection risk to patients.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class I recall, which requires a minimum severity score of 4 per the rubric rules. Non-sterile cardiac catheters pose a serious infection risk to patients during invasive cardiac procedures.
Plain-English summary
Cordis US Corp is recalling Cordis ANGIOGRAPHIC CATHETERIZATION SETS, INFINITI THRULEMEN, 5F (Reference CO0208) due to a critical labeling and sterility issue. The devices, intended for cardiac catheterization procedures, were manufactured non-sterile but distributed with sterile labels. This creates a serious patient safety hazard by potentially exposing patients to bacterial or viral infections during cardiac catheterization.
The recall affects 30 devices with Lot Number 18223410 and UDI/DI 10705032025935, distributed in the United States to Oklahoma. Healthcare facilities and interventional cardiologists in the affected area should cease use of products from this lot and contact Cordis US Corp immediately.
If your facility received devices from this lot, do not use them for patient procedures. Remove them from inventory and return them to Cordis US Corp. Patients who may have received cardiac catheterization with these devices should contact their healthcare provider immediately to discuss potential infection risks.
The recalled product
- Product
- Cordis ANGIOGRAPHIC CATHETERIZATION SETS, INFINITI THRULEMEN, 5F, REF CO0208, cardiac catheter
- Manufacturer
- Cordis US Corp
- Hazard
- non-sterile
- mis-labeling
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 (2)
- UDI/DI 10705032025935
- Lot Number 18223410
Distribution
Distributed in 1 state:
- OK
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