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 a breach of the sterile barrier may compromise sterility, but no injuries or illnesses have been reported.
Plain-English summary
Terumo Medical Corp is recalling specific lots of the Glidesheath Slender Hydrophilic Coated Introducer Sheath, 5FR - 16CM (0.021). The recall affects product with reference code RM*RS5F16PA, which is sterile and prescription-only. The affected lots are 161107, 170209, 170307, and 170406.
The recall was initiated because an incomplete seal was detected at the chevron end of the primary packaging. This defect was found in a small quantity of the affected lot population, representing 0.01% (1 in 10,000 units). The breach of the sterile barrier may compromise the sterility of the sheath.
The product was distributed nationwide and in Canada. Healthcare providers and patients should check their inventory for the specific lot numbers listed and stop using any affected units. No specific instructions for disposal or return are provided in the source text.
The recalled product
- Product
- Glidesheath Slender Hydrophilic Coated Introducer Sheath, 5FR - 16CM (0.021), REF/Product Code RM*RS5F16PA, STERILE, Rx ONLY
- Manufacturer
- Terumo Medical Corp
- Hazard
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 161107
- 170209
- 170307
- 170406
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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