Reported Jul 30, 2014 · Terminated
Terumo Three-stage Venous Return Cannulae 28 Fr with 3/8" flare, 30 Fr with 3/8" connector and 30 Fr with 3/8" flare.…
Terumo Cardiovascular Systems Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Terumo Cardiovascular Systems Corporation · 6200 Jackson Rd · Ann Arbor, MI · 48103-9586
Is this the product you have?
- Terumo Three-stage Venous Return Cannulae 28 Fr with 3/8" flare, 30 Fr with 3/8" connector and 30 Fr with 3/8" flare
- Product UsageVenous Return Cannula is indicated for venous drainage during cardiopulmonary bypass surgery for dual cannulation of the superior and inferior vena cava
- Lot codes and dates
28 Fr with 3/8" flarePart No816460Lot #:064528006491570654734066668606748100678724068222106847900698319069891030 Fr with 3/8" connectorPart No820732Lot #:646450 & 30 Fr with 3/8" flarePart No820731Lot #:06898430698323
- Amount recalled
- 2,290 units
This recall covers 13 products
The agency filed one notice per product. You are reading one of them; the other 12 are below.
Where it was sold
Why it was recalled
During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose fiber particulate that exceeded finished product specifications
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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