Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1612-2013·Announced 2013-07-03

Terumo Glidesheath Recalled for Incorrect Expiration Date Labeling

Terumo Medical Corporation is recalling 550 units of Glidesheath products due to incorrect expiration date labeling.

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 criteria for moderate severity involving minor labeling errors or low-risk issues.

Plain-English summary

Terumo Medical Corporation is recalling 550 units of Terumo Glidesheath (tm), 6 French, Nitinol wire, product code 15-1060. These medical devices are used to facilitate placing a catheter through the skin into a vein or artery. The recall is limited to Lot MP08.

The recall was initiated because the medical devices were incorrectly labeled with extended expiration dates. This labeling error could potentially affect the safety or efficacy of the product if used past its intended expiration date.

The affected products were distributed nationwide. Healthcare facilities and distributors should stop using the recalled units and contact Terumo Medical Corporation for further instructions on return or replacement.

The recalled product

Product: Terumo Glidesheath (tm), 6 French, Nitinol wire, product code 15-1060. Used to facilitate placing a catheter through the skin into a vein or artery.
Manufacturer: Terumo Medical Corporation
Category: Medical Device — Catheter Accessories
Hazard: mis-labeling
Affected units: 550

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 MP08

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.

See all 2 products in this recall →

Same manufacturer · Terumo Medical Corporation

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Same hazard · mis labeling