Reported Jul 30, 2014 · Terminated
Terumo Dual-stage Venous Return Cannulae 28/38, 29/37, 32/40, 34/46, 36/46 & 36/51 Fr with 1/2" flare or connector…
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 Dual-stage Venous Return Cannulae 28/38, 29/37, 32/40, 34/46, 36/46 & 36/51 Fr with 1/2"
- flare or connector 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
11 of 11 products
Products covered by this recall Model / number Product as published 813580Lot #: AM004245, AM006060, AM016524 813579Lot #: AM001313, AM007311, AM007721, AM009067, AM016176, AM016523, AM018165 813582Lot #: AM001293, AM017320 813581Lot #: AM002694, AM003543, AM006059, AM017959 813584Lot #: AM001311, AM002688, AM002730, AM006055, AM016188, AM016639 813583Lot #: AM002729, AM006054, AM016187, AM016638, AM018071 813586Lot #: AM001303, AM005726, AM006061, AM008349 813585Lot #: AM002473, AM002728, AM006056, AM010935, AM017208 813588Lot #: AM002690, AM002699, AM003781, AM004252, AM006058, AM008238, AM016477 813587Lot #: AM001314, AM002687, AM003782, AM006057, AM008237, AM016189, AM016476, AM018297 813589Part No. 813590, Lot #: AM016920 & , Lot #: AM002720, AM004287. - Amount recalled
- 34,470 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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