Terumo Pinnacle Destination Peripheral Guiding Sheath Recalled for Labeling Error
Terumo Medical Corporation is recalling 20 units of Pinnacle Destination Peripheral Guiding Sheaths because they were incorrectly labeled with extended expiration dates.
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 involves a labeling error regarding expiration dates, which fits the rubric for moderate severity involving minor labeling errors or low-risk issues.
Plain-English summary
Terumo Medical Corporation is recalling 20 units of Pinnacle Destination Peripheral Guiding Sheaths, 8 French, 90cm, Straight Tip, Cross Cut Valve. The product is identified by Lot MM27 and was distributed nationwide.
The recall was initiated because the medical devices were incorrectly labeled with extended expiration dates. The sheaths act as a conduit to facilitate the introduction of interventional and diagnostic devices into the human vasculature.
Healthcare providers and facilities should check their inventory for this specific lot and stop using the affected units. Consumers are not directly affected as this is a professional medical device.
The recalled product
- Product
- Pinnacle¿ Destination¿ Peripheral Guiding Sheath, 8 French, 90cm, Straight Tip, Cross Cut Valve. Acts as a conduit to facilitate the introduction of interventional and diagnostic devices into the human vasculature.
- Manufacturer
- Terumo Medical Corporation
- Category
- Medical Device — Vascular Access
- Hazard
- Affected units
- 20
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 (1)
- Lot MM27
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Terumo Medical 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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