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Cordis ANGIOGRAPHIC CATHETERIZATION SETS, INFINITI THRULEMEN, 5F, REF CO0208, cardiac catheter

FDA Recall #Z-0286-2024 — Class I — September 26, 2023

Recall #Z-0286-2024 Date: September 26, 2023 Classification: Class I Status: Ongoing

Product Description

Cordis ANGIOGRAPHIC CATHETERIZATION SETS, INFINITI THRULEMEN, 5F, REF CO0208, cardiac catheter

Reason for Recall

Non-sterile product labeled as sterile was distributed.

Recalling Firm

Cordis US Corp — Miami Lakes, FL

Classification

Class I — Reasonable probability of serious adverse health consequences or death.

Product Type

Devices

Product Quantity

30 devices

Distribution

US Distribution to: OK

Code Information

UDI/DI 10705032025935, Lot Number 18223410

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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