Terumo Recalls Glidesheath Introducer Sheath Due to Incomplete Seal
Terumo Medical Corp is recalling a specific lot of Glidesheath Introducer Sheaths because an incomplete seal may compromise sterility.
What this means for you
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 breach of the sterile barrier, which is a low-risk contamination issue without reported illnesses or injuries in the source text, fitting the criteria for a moderate severity score.
Plain-English summary
Terumo Medical Corp is recalling the Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 5FR - 16CM (0.021), Lot 170316. The recall is due to an incomplete seal at the chevron end of the primary packaging, which was detected in a small quantity of the affected lot population (0.01% or 1 in 10,000 units). This breach of the sterile barrier may compromise the sterility of the sheath.
The affected product was distributed nationwide and in Canada. The product is sterile and requires a prescription (Rx ONLY). No specific dates or additional distribution details are provided in the source text.
Healthcare providers and consumers should stop using the affected product and contact Terumo Medical Corp for further instructions or a replacement.
The recalled product
- Product
- Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 5FR - 16CM (0.021), REF/Product Code RM*ES5F16HAU, 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 (1)
- Lot 170316
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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