Terumo TenderFlow Pediatric Venous Cannulae Recalled for Loose Fiber Particulate
Terumo CVS is recalling specific lots of TenderFlow Pediatric Venous Cannulae due to loose fiber particulate exceeding specifications found during inspection.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text describes a manufacturing deviation (loose fiber particulate) without reporting any specific injuries, illnesses, or deaths, fitting the criteria for a moderate severity recall.
Plain-English summary
Terumo Cardiovascular Systems Corporation is recalling specific lots of Terumo TenderFlow Pediatric Venous Cannulae. The recall was initiated after an in-process inspection identified the presence of loose fiber particulate that exceeded finished product specifications.
The affected products are indicated for venous drainage during cardiopulmonary bypass surgery for dual cannulation of the superior and inferior vena cava. The recall covers 14,380 units distributed worldwide, including nationwide distribution in the United States and in several international countries such as Australia, Canada, and the United Kingdom.
Healthcare providers and facilities should check their inventory for the specific part numbers and lot numbers listed in the recall notice. If the affected products are found, they should be removed from use and returned to Terumo CVS according to the company's instructions.
The recalled product
- Product
- Terumo TenderFlow Pediatric Venous Cannulae, 8, 10, 12, 14, 16, 18, 20, 22 & 24 Fr angled & straight tip, 1/4" & 3/8" flare, Product Usage: Venous Return Cannula is indicated for venous drainage during cardiopulmonary bypass surgery for dual cannulation of the superior and…
- Manufacturer
- Terumo Cardiovascular Systems Corporation
- Affected units
- 14,380
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Part No. 813542
- Lot #: AM000378
- Part No. 813541
- Lot #: AM002689
- Part No. 813544
- Lot #: AM006016
- AM017817
- Part No. 813546
- Lot #: AM002709
- AM006018
- AM006048
- AM017262
- Part No. 813545
- Lot #: AM002705
- AM006046
- AM007636
- Part No. 813548
- Lot #: AM002707
- AM006050
- AM017681
Distribution
Part of a larger recall action
This product is one of 13 recalled by Terumo Cardiovascular Systems Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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