Terumo Backplate Replacement CXFVR 1500 Holder Recalled for Incorrect Configuration
Terumo is recalling 33 Backplate Replacement CXFVR 1500 Holders because they were manufactured with an incorrect configuration of connector supports.
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 configuration error without reporting any illnesses, injuries, or deaths, fitting the criteria for a moderate severity score.
Plain-English summary
Terumo Cardiovascular Systems Corporation is recalling 33 units of the Backplate Replacement CXFVR 1500 Holder. The recall is due to a manufacturing error where the devices were configured with two 3/8 inch and one 1/4 inch connector supports instead of the correct configuration of one 3/8 inch and two 1/4 inch connector supports.
The affected devices were distributed worldwide, including nationwide in the United States (specifically California, Michigan, North Carolina, New Jersey, Pennsylvania, and Wisconsin) and in Europe. The products are identified by catalog number PN 816280, and no specific lot or serial numbers are associated with the recall.
Healthcare providers and users should stop using the affected Backplate Replacement CXFVR 1500 Holders and contact Terumo Cardiovascular Systems Corporation for instructions on how to return or replace the devices.
The recalled product
- Product
- Terumo Backplate Replacement CXFVR 1500 Holder The Flexible venous Reservoir is mounted on the Backplate/Holder and secures the flexible reservoir by strategically placed mounting arms. Additionally, there are three port supports the user incorporates to position the lines…
- Manufacturer
- Terumo Cardiovascular Systems Corporation
- Category
- Medical Device — Cardiovascular
- Hazard
- Affected units
- 33
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 (2)
- No lot/serial number
- Catalog number: PN 816280
Distribution
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