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.
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, which typically corresponds to a moderate severity score. The defect affects a very small percentage of units (0.01%) and involves a potential sterile barrier breach rather than a confirmed contamination or injury.
Plain-English summary
Terumo Medical Corp is voluntarily recalling specific lots of the Glidesheath Slender Hydrophilic Coated Introducer Sheath, 6FR - 10CM (0.021), REF/Product Code RM*CS6F10NA. The recall affects Lots 161116 and 170113, which were 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 the affected product codes and lot numbers. If the product is found, it should be removed from use and returned to Terumo Medical Corp in accordance with their recall instructions.
The recalled product
- Product
- Glidesheath Slender Hydrophilic Coated Introducer Sheath, 6FR - 10CM (0.021), REF/Product Code RM*CS6F10NA, 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 (2)
- Lots 161116
- 170113
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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