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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (sterile medical device) where the sterile barrier is compromised, but no injuries or illnesses have been reported in the source text.
Plain-English summary
Terumo Medical Corp is voluntarily recalling specific lots of Glidesheath Slender Hydrophilic Coated Introducer Sheaths. The recall involves 6FR - 10CM (0.025) units with product code RM*RS6J10PA. The affected lots are 161115, 161130, 161207, and 170116.
The recall was initiated because an incomplete seal was detected at the chevron end of the primary packaging in a small quantity of the affected lot population. This breach of the sterile barrier may compromise the sterility of the sheath. The defect was found in approximately 0.01% (1 in 10,000 units) of the affected lots.
The affected products were distributed nationwide and in Canada. Healthcare providers and facilities should check their inventory for the specific lot numbers listed above and stop using any affected units. Consumers should contact their healthcare provider for guidance if they have received or used these specific products.
The recalled product
- Product
- Glidesheath Slender Hydrophilic Coated Introducer Sheath, 6FR - 10CM (0.025), REF/Product Code RM*RS6J10PA, 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 (4)
- Lot s 161115
- 161130
- 161207
- 170116
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
- ModerateTerumo Recalls Glidesheath Introducer Sheaths Due to Packaging Seal Defect
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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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