CLASS II Device recall · Reported 6 Mar 2019 · FDA Enforcement Report
Cardiovascular Procedure Kit (Clr MP4 Coil 2 Spike) recalled
Terumo Cardiovascular Systems is recalling Cardiovascular Procedure Kit (Clr MP4 Coil 2 Spike), distributed in Texas. The recall was initiated on 20 Dec 2018 and the FDA has classified it as Class II.
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-0966-2019
- FDA event ID
- 82019
- Recalling firm
- Terumo Cardiovascular Systems, Elkton, MD
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 20 Dec 2018
- FDA classified
- 27 Feb 2019
- Reported
- 6 Mar 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Labeling Errors
- Device type
- Heart & Vascular Devices
Timeline
| 20 Dec 2018 | Recall initiated by company | |
| 27 Feb 2019 | Classified by FDA | +69 days |
| 6 Mar 2019 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of natural rubber latex is not declared in the label
Product as listed by the FDA
Cardiovascular Procedure Kit (CLR MP4 COIL 2 SPIKE) Catalog Number: 140222
Where it was distributed
TX
Questions about this recall
Why was it recalled?
Presence of natural rubber latex is not declared in the label
Which lots are affected?
Lot Numbers: V A30
Where was it sold?
TX
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
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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