Terumo Recalls Glidesheath Introducer Sheaths Due to Packaging Seal Defect
Terumo Medical Corp is recalling specific lots 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, and the source text indicates a low defect rate (0.01%) with no reported illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Terumo Medical Corp is recalling the Glidesheath Slender Hydrophilic Coated Introducer Sheath, 5FR - 10CM (0.021), REF/Product Code RM*CS5F10NA. The recall affects Lot 161104, which was distributed nationwide and in Canada.
The recall was initiated because an incomplete seal at the chevron end of the primary packaging was detected in a small quantity of the affected lot population, representing 0.01% (1 in 10,000 units). This breach of the sterile barrier may compromise the sterility of the sheath.
Healthcare providers and facilities should check their inventory for this specific product code and lot number. If the product is found, it should be removed from use and returned to the manufacturer or disposed of according to local regulations.
The recalled product
- Product
- Glidesheath Slender Hydrophilic Coated Introducer Sheath, 5FR - 10CM (0.021), REF/Product Code RM*CS5F10NA, 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 161104
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.
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