Reported Jul 30, 2014 · Terminated
Sarns Two-stage Venous Return Cannulae 32/40 & 36/51 Fr with 1/2" & 3/8" flare or connector Product Usage: The Venous…
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?
- Sarns Two-stage Venous Return Cannulae 32/40 & 36/51 Fr with 1/2" & 3/8"
- flare or connector Product UsageThe Venous 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
3 of 3 products
Products covered by this recall Model / number Product as published 4442Lot #:, 0646528, 0649147, 0649840, 0654076, 0662223, 0678729 14992Lot #: 0646475, 0649160, 0655317, 0659466, 0666649, 0672081, 0675675, 0681806, 0686885 15949Part No. 4443, Lot #: 0649883, 0660672 & , Lot #: 0646530, 0661896, 0667259, 0674784, 0683631. - Amount recalled
- 6,720 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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