Cardiovascular Procedure Kit, P/N 70579-04, St. Louis… recallZ-1313-2008 · Terumo Cardiovascular Systems Corp · initiated Jan 29, 2008
Terminated All recalls posted in March 2008
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
Loose Flash at tip of Weighted Flexible Sucker: A loose strand of stainless steel left on the device during manufacturing by an outside supplier may result in an unretrieved metal fragment remaining in the patient.
FDA root cause category: Nonconforming Material/Component
What the company is doing
Consignees were notified via recall letter, Urgent Medical Device Removal, dated 1/29/08 via fax or email to cease using the weighted sucker in the packs and to use an alternative sucker until replacement product arrives from Terumo.
Recall details
- Recall number
- Z-1313-2008
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Jan 29, 2008
- Posted by the FDA
- Mar 28, 2008
- Recalling firm
- Terumo Cardiovascular Systems Corp
- Quantity
- 252
- Product code
- OEZ
- FDA submissions
- K982891
- Distribution
- Nationwide-USA including states of Missouri, Tennessee and Wisconsin-Custom Kits for 3 hospitals.
Product description
Cardiovascular Procedure Kit, P/N 70579-04, St. Louis University Hospital Pump & Table Pack, Terumo Cardiovascular, Ashland, MA. (the Pump & Table pack contains a weighted flexible sucker, Catalog No. 804113)
Code information (models, lots, serial numbers)
Lot Numbers: GC20, GE24, GF22, GG12, GH17, GL25, GN06, HA22, HD19, HF07, HG18 and HM08.
Other devices under the same FDA submission
4 devices cleared under K982891 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Suction tip SU-xxxxxLivanova USA, Inc. · SUCKER, CARDIOTOMY RETURN, CARDIOPULMONARY BYPASS9 reports
- Suction tip SU-xxxxxLivanova USA, Inc. · SUCKER, CARDIOTOMY RETURN, CARDIOPULMONARY BYPASS6 reports
- Suction tip SU-xxxxxLivanova USA, Inc. · SUCKER, CARDIOTOMY RETURN, CARDIOPULMONARY BYPASS2 reports
- Suction tip SU-xxxxxLivanova USA, Inc. · SUCKER, CARDIOTOMY RETURN, CARDIOPULMONARY BYPASS2 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 46869).
- Z-1310-2008 · TerminatedCardiovascular Procedure Kit, P/N: 70932-01, HCSG-St. Mary's Hospital, Richmond, VA , X-coated Pump and Table Pack, Terumo Cardiovascular, Ashland, MA (the X-coated pump and table …
- Z-1311-2008 · TerminatedCardiovascular Procedure Kit, P/N 64789-01, Wisconsin Cardiovascular Services Pump and Table Pack, Terumo Cardiovascular, Ashland, MA. (the Pump & table pack contains a weighted fl…
- Z-1312-2008 · TerminatedCardiovascular Procedure Kit, P/N 70295-02, St. Louis University Hospital Pump & Table Pack, Terumo Cardiovascular, Ashland, MA. ( Pump & table pack contains a weighted flexible…
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.
How recalls are matched to devices · Editorial policy · Report an error on this page