CLASS I ONGOING Device recall · Reported 15 Nov 2023 · FDA Enforcement Report
Cordis Angiographic Catheterization Sets, Infiniti Thrulemen, 5F recalled
Cordis US is recalling Cordis Angiographic Catheterization Sets, Infiniti Thrulemen, 5F, distributed in Oklahoma. The recall was initiated on 26 Sep 2023 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0286-2024
- FDA event ID
- 93174
- Recalling firm
- Cordis US, Miami Lakes, FL
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 26 Sep 2023
- FDA classified
- 9 Nov 2023
- Reported
- 15 Nov 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Sterility
- Device type
- Heart & Vascular Devices
Timeline
| 26 Sep 2023 | Recall initiated by company | |
| 9 Nov 2023 | Classified by FDA | +44 days |
| 15 Nov 2023 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Non-sterile product labeled as sterile was distributed.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Cordis ANGIOGRAPHIC CATHETERIZATION SETS, INFINITI THRULEMEN, 5F, REF CO0208, cardiac catheter
Where it was distributed
US Distribution to: OK
Questions about this recall
Why was it recalled?
Non-sterile product labeled as sterile was distributed.
Which lots are affected?
UDI/DI 10705032025935, Lot Number 18223410
Where was it sold?
US Distribution to: OK
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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