Reported Jul 30, 2014 · Terminated
Sarns Malleable Venous Return Cannulae 24, 28, 30, 32, 34, 36 & 40 Fr single stage with 3/8" & 1/2 flare with or…
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 Malleable Venous Return Cannulae 24, 28, 30, 32, 34, 36 & 40 Fr single stage with 3/8" & 1/2 flare
- with or without Xcoating 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
12 of 12 products
Products covered by this recall Model / number Product as published 4881Lot #: 0646527, 0652247, 0655237, 0657761, 0659431, 0663547, 0666625, 0674022, 0676975, 0678722, 0681793, 0693318, 0695683, 0697379 4881XLot #: 684032 4882Lot #: 0646526, 0649165, 0650782, 0653857, 0657248, 0662811, 0668349, 0673863, 0676584, 0678953, 0682571, 0683601, 683601R 4882XLot #: 0651693, 0656946, 0668566, 0683306, 683306R 4883Lot #: 0647472, 0653433, 0658525, 0659432, 0662541, 0673755, 0676593, 0681816, 0691567, 0696613 4883XLot #: 0649154, 0653823, 0675680 4884Lot #: 0646143, 0647046, 0649882, 0652246, 0654605, 0662807, 0667262, 0670484, 0674103, 0677804, 0683383, 0683605, 0692771, 0696611 4884XLot #: 0649169, 0653445, 0683608 4885Lot #: 0647474, 0652803, 0655236, 0662804, 0670673, 0675804, 0677976, 0681127, 0695872, 0698980 4885XLot #: 0652526, 0662887 4886Lot #: 0659433, 0661555, 0667893, 0669797, 0681817 4887Part No. 4886X, Lot #: 652528 & , Lot #: 0661530, 0668567, 0672138. - Amount recalled
- 32,880 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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