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
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 sterile medical device where a packaging defect may compromise sterility, representing a risk of harm (infection) even though no specific injuries are reported in the source text.
Plain-English summary
Terumo Medical Corp is voluntarily recalling specific lots of Glidesheath Slender Hydrophilic Coated Introducer Sheaths, 6FR - 16CM (0.021). The recall affects product with reference code RM*RS6F16PA. The affected lots are 161116, 161213, 170117, 170213, and 170308. The product was distributed nationwide and in Canada.
The recall was initiated because an incomplete seal was detected at the chevron end of the primary packaging. This defect affects a small quantity of the affected lot population, estimated at 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 specific lot numbers listed above. If the product is found, it should be removed from use and returned to Terumo Medical Corp or the distributor.
The recalled product
- Product
- Glidesheath Slender Hydrophilic Coated Introducer Sheath, 6FR - 16CM (0.021), REF/Product Code RM*RS6F16PA, 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 (5)
- Lot s 161116
- 161213
- 170117
- 170213
- 170308
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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