Terumo Destination Guiding Sheath Recalled for Specification Deviation
Terumo Medical Corporation is recalling 33 units of Destination Guiding Sheath catheter introducers because the tucking depth feature is marginally outside the upper specification.
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 describes a marginal specification deviation without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Terumo Medical Corporation is recalling 33 units of the Destination Guiding Sheath catheter introducer, Catalog Number RSR06. The recall is limited to Lot VK09 with an expiration date of 31-Jan-2020.
The recall was initiated because the tucking depth feature of the catheter introducer is marginally outside the upper specification. The Destination Guiding Sheath is designed to be used for the introduction of interventional and diagnostic devices into the human vasculature, including the renal, carotid, and peripheral arteries.
The distribution pattern for these units is listed as 'To be added.' in the source documentation. No specific illnesses, injuries, or deaths are reported in the source text.
The recalled product
- Product
- Destination Guiding Sheath catheter introducer, Catalog Number: RSR06 Product Usage: The Destination¿ Guiding Sheath is designed to be used for the introduction of interventional and diagnostic devices into the human vasculature, including but not limited to the renal…
- Manufacturer
- Terumo Medical Corporation
- 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)
- Lot: VK09
- Expiration Date: 31-Jan-2020
Distribution
Distribution scope not specified by the agency.
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