Cardiovascular Procedure Kit recallZ-0949-2022 · Terumo Cardiovascular Systems Corp · initiated Feb 3, 2022
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Terumo Cardiovascular Systems Corp or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Potential for Cardiovascular Procedure Kit packaging damage that occurred during shipping.
FDA root cause category: Under Investigation by firm
What the company is doing
A customer notification letter was issued on 02/23/2022 by 2-day FedEx mailing advising customers to remove the affected product from use and return to Terumo CVS using the instructions provided.
Recall details
- Recall number
- Z-0949-2022
- Status
- Terminated
- Initiated by the company
- Feb 3, 2022
- Recalling firm
- Terumo Cardiovascular Systems Corp
- Quantity
- 64
- Product code
- OEZ
- Distribution
- US Nationwide distribution in the states of CA and IN.
Product description
Cardiovascular Procedure Kit catalog # 76645 & 73806
Code information (models, lots, serial numbers)
[Lot #Z15957677, case label GTIN: (01)00699753507685, product identifier: (17)230228(10)Z15957677] and [Lot #Z16958398, case label GTIN: (01)00699753477728, product identifier: (17)230228(10)Z16958398]
Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
- Cardiovascular Procedure Kit 73806Terumo Cardiovascular Systems Corporation1 recall0 reports
- Cardiovascular Procedure Kit 76645Terumo Cardiovascular Systems Corporation1 recall0 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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