Terumo Recalls Sarns Malleable Venous Return Cannulae Due to Particulate
Terumo CVS is recalling Sarns Malleable Venous Return Cannulae because in-process inspections found loose fiber particulate exceeding specifications.
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. The source text does not report any illnesses, injuries, or hospitalizations, and the hazard is a particulate issue identified during inspection, fitting the criteria for a moderate severity rating.
Plain-English summary
Terumo Cardiovascular Systems Corporation is recalling Sarns Malleable Venous Return Cannulae in sizes 24, 28, 30, 32, 34, 36, and 40 Fr. The devices are indicated for venous drainage during cardiopulmonary bypass surgery for dual cannulation of the superior and inferior vena cava.
The recall was initiated after an in-process inspection identified the presence of loose fiber particulate that exceeded finished product specifications. The affected units include 32,880 devices distributed worldwide, including nationwide in the United States and in several international markets.
Healthcare facilities should stop using the affected devices and contact Terumo CVS for further instructions. The recall covers specific part numbers and lot numbers listed in the official FDA record.
The recalled product
- Product
- 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 Usage: The Venous Return Cannula is indicated for venous drainage during cardiopulmonary bypass surgery for dual cannulation of the…
- Manufacturer
- Terumo Cardiovascular Systems Corporation
- Hazard
- Affected units
- 32,880
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. 4881
- Lot #: 0646527
- 0652247
- 0655237
- 0657761
- 0659431
- 0663547
- 0666625
- 0674022
- 0676975
- 0678722
- 0681793
- 0693318
- 0695683
- 0697379
- Part No. 4881X
- Lot #: 684032
- Part No. 4882
- Lot #: 0646526
- 0649165
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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Similar recalls
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