Terumo Recalls Glidesheath Introducer Sheaths Due to Incomplete Packaging Seal
Terumo Medical Corp is recalling specific lots of Glidesheath Introducer Sheaths because an incomplete seal may compromise sterility.
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 hazard is a potential sterility breach affecting a very small percentage of units (0.01%), with no reported illnesses or injuries in the source text, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Terumo Medical Corp is recalling specific lots of the Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit. The recall affects the 5FR - 10CM (0.025) size with product code RM*ES5J10HAT. The affected lots are 161110, 161214, and 170119.
The recall was initiated because an incomplete seal was detected at the chevron end of the primary packaging. This defect occurred in a small quantity of the affected lot population, specifically 0.01% (1 in 10,000 units). This breach of the sterile barrier may compromise the sterility of the sheath.
The product was distributed nationwide and in Canada. Healthcare providers and facilities should check their inventory for these specific lot numbers and stop using the affected units.
The recalled product
- Product
- Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 5FR - 10CM (0.025), REF/Product Code RM*ES5J10HAT, STERILE, Rx ONLY
- Manufacturer
- Terumo Medical Corp
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 (3)
- Lot 161110
- 161214
- 170119
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 17 recalled by Terumo Medical Corp 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 17 products in this recall →Related recalls
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FDA (Devices) · 2018-07-11
- HighTerumo Recalls Glidesheath Introducer Sheaths Due to Incomplete Packaging Seal
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- ModerateTerumo Recalls Glidesheath Introducer Sheaths Due to Packaging Seal Defect
FDA (Devices) · 2017-12-20
- ModerateTerumo Recalls Glidesheath Introducer Sheaths Due to Packaging Seal Defect
FDA (Devices) · 2017-12-20
- HighTerumo Recalls Glidesheath Introducer Sheaths Due to Incomplete Packaging Seal
FDA (Devices) · 2017-12-20
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