Cardiovascular Procedure Kit, (MP4 w/ Conducer Component… recallZ-2615-2010 · Terumo Cardiovascular Corporation · initiated Jun 8, 2010
Terminated All recalls posted in September 2010
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 Corporation 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
Medical device vent port may be occluded and prevent delivery of priming fluid.
FDA root cause category: Equipment maintenance
What the company is doing
Consignees were contacted on June 8, 2010, by phone, fax, email and priority mail to advise distributors and end-users of the potential occluded vent port defect and provide instructions for the replacement product recall. Consignees were mailed follow-up communications by priority overnight mail on June 9, 2010.
Recall details
- Recall number
- Z-2615-2010
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Jun 8, 2010
- Posted by the FDA
- Sep 29, 2010
- Recalling firm
- Terumo Cardiovascular Corporation
- Quantity
- 110 kits
- Product code
- DTR
- FDA submissions
- K900640
- Distribution
- The products were distributed nationwide.
Product description
Cardiovascular Procedure Kit, (MP4 w/ Conducer Component Utilized), labeled in part ***RWJ Hospital***, Item # 71305-03
Code information (models, lots, serial numbers)
Lot numbers: MD15, and MD26
Other devices under the same FDA submission
2 devices cleared under K900640 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Sarns™ Cardioplegia Set 165720Terumo Cardiovascular Systems Corporation · Heat-Exchanger, Cardiopulmonary Bypass1 recall0 reports
- Sarns™ Cardioplegia Set 6375Terumo Cardiovascular Systems Corporation · Heat-Exchanger, Cardiopulmonary Bypass1 recall0 reports
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 18, 2026. Text above is shown as published by the FDA.
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