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 does not report any illnesses or injuries, fitting the criteria for a moderate severity score involving low-risk contamination or voluntary precautionary measures.
Plain-English summary
Terumo Medical Corp is recalling specific lots of the Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 6FR - 10CM (0.021). The recall affects units 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. This breach of the sterile barrier may compromise the sterility of the sheath.
Healthcare providers and facilities should check their inventory for the specific lot numbers listed in the recall notice and stop using any affected units.
The recalled product
- Product
- Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 6FR - 10CM (0.021), REF/Product Code RM*ES6F10HAU, 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 (14)
- Lot s161019
- 161102
- 161103
- 161118
- 161201
- 161202
- 161205
- 161215
- 161216
- 170109
- 170110
- 170111
- 170202
- 17023
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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- 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
- HighTerumo Recalls Glidesheath Introducer Sheaths Due to Incomplete Packaging Seal
FDA (Devices) · 2017-12-20
- ModerateTerumo Recalls Glidesheath Introducer Sheaths Due to Packaging Seal Defect
FDA (Devices) · 2017-12-20
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