Terumo Cardiovascular Procedure Kit Custom recallZ-2152-2010 · Terumo Cardiovascular Systems Corp · initiated Jun 8, 2010
Terminated All recalls posted in August 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 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
Vent port may be occluded and prevent delivery of fluid
FDA root cause category: Equipment maintenance
What the company is doing
Terumo, Ashland, MA notified consignees on 6/8/10, by phone, fax, email and mail to advise distributors and end-users of the required recall actions. Follow-up communication sent by priority overnight mail on 6/9/10, with proof of delivery, specifying the awareness to the issue and necessary correction activities should a unit be discovered. Phase 2 initiated on 7/1/10 to sale rep to remove recalled product and perform a product reconciliation to ensure that all affected product is identified, returned to Terumo CVS, and that replacement product is sent immediately.
Recall details
- Recall number
- Z-2152-2010
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Jun 8, 2010
- Posted by the FDA
- Aug 2, 2010
- Recalling firm
- Terumo Cardiovascular Systems Corp
- Quantity
- 52 packs
- Product code
- DTR
- FDA submissions
- K823451
- Distribution
- Distribution USA and Canada
Product description
Terumo Cardiovascular Procedure Kit Custom 8:1 CARDIOPLEGIA SET P/N 70608-01
Code information (models, lots, serial numbers)
Lots: ME19, ME26
Other devices under the same FDA submission
1 device cleared under K823451 — 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 16010Terumo Cardiovascular Systems Corporation · Heat-Exchanger, Cardiopulmonary Bypass1 recall0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 56037).
- Z-2149-2010 · TerminatedTerumo Cardiovascular Procedure Kit Custom Open Perfusion Pack P/N 64937
- Z-2150-2010 · TerminatedTerumo Cardiovascular Procedure Kit Custom 1:1 CONDUCER/MP4 CRYSTALLOID CARDIOPLEGIA P/N 65246
- Z-2151-2010 · TerminatedTerumo Cardiovascular Procedure Kit Custom MP4, 4:1, PRELIEF, W/RECIRC, COND / PUMP & TABLE PACK P/N 65503/70881-02
- Z-2153-2010 · TerminatedTerumo Cardiovascular Procedure Kit Custom X-COATED ADULT PRESTIGE PACK P/N 71544-01
- Z-2154-2010 · TerminatedTerumo Cardiovascular Procedure Kit Custom ADULT PACK P/N 71546-01
- Z-2155-2010 · TerminatedTerumo Cardiovascular Procedure Kit Custom PERFUSION TUBING PACK P/N 71733
- Z-2156-2010 · TerminatedTerumo Cardiovascular Procedure Kit Custom X-COATED HEART/LUNG FRAMEPACK P/N 71766PP
- Z-2157-2010 · TerminatedTerumo Cardiovascular Procedure Kit Custom X-COATED PERFUSION PACK P/N 71934
- Z-2158-2010 · TerminatedTerumo Cardiovascular Procedure Kit Custom X-COATED PUMP AND TABLE PACK W/8:1 CARDIOPLEGIA P/N 72642
- Z-2159-2010 · TerminatedTerumo Cardiovascular Procedure Kit Custom X-COATED MASTER PACK P/N 72790
- Z-2160-2010 · TerminatedTerumo Cardiovascular Procedure Kit Custom X-COATED ADULT PACK P/N 72846
- Z-2161-2010 · TerminatedTerumo Cardiovascular Procedure Kit Custom ADULT PACK P/N: 131351-02
- Z-2162-2010 · TerminatedTerumo Cardiovascular Procedure Kit Custom X-COATED HEART - LUNG PACK P/N: 70608-01
- Z-2163-2010 · TerminatedTerumo Cardiovascular Procedure Kit Custom CONDUCER/MP4 8:1 NO RECIRC. DOUBLE SPIKE P/N: 71032
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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