Reported Jul 30, 2014 · Terminated
Terumo TenderFlow Pediatric Venous Cannulae, 8, 10, 12, 14, 16, 18, 20, 22 & 24 Fr angled & straight tip, 1/4" & 3/8"…
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 TenderFlow Pediatric Venous Cannulae810121416182022 & 24 Fr angled & straight tip1/4" & 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
20 of 20 products
Products covered by this recall Model / number Product as published 813542Lot #: AM000378 813541Lot #: AM002689 813544Lot #: AM006016, AM017817 813546Lot #: AM002709, AM006018, AM006048, AM017262 813545Lot #: AM002705, AM006046, AM007636 813548Lot #: AM002707, AM006050, AM017681 813547Lot #: AM002697, AM006020, AM007724 813550Lot #: AM001312, AM004268, AM007732, AM018316 813549Lot #: AM002717, AM006052, AM007637 813552Lot #: AM003778, AM007725 813554Lot #: AM001309 813551Lot #: AM002702, AM007635 813553Lot #: AM002708 813556Lot #: AM007733 813555Lot #: AM002719 813557Lot #: AM007726 813560Lot #: AM018160 813559Lot #: AM008235 813561Lot #: AM007639 813565Part No. 813566, Lot #: AM004227, AM017924 & , Lot #: AM001315, AM006072. - Amount recalled
- 14,380 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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