The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0217-2018·Announced 2017-12-20

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, but the defect affects only 0.01% of units and no illnesses or injuries are reported, fitting the criteria for a moderate risk.

Plain-English summary

Terumo Medical Corp is recalling specific lots of Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kits. The recall involves units with product code RM*ES5F10HAU and lot numbers s161118, 161206, and 170119. These products were 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). The 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 and product codes listed above. If these units are found, they should be removed from use and returned to the manufacturer or disposed of according to local regulations.

The recalled product

Product
Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 5FR - 10CM (0.021), REF/Product Code RM*ES5F10HAU, STERILE, Rx ONLY
Manufacturer
Terumo Medical Corp
Category
Medical Device — Introducer Sheath
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 (3)

  • Lot s161118
  • 161206
  • 170119

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 →

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