Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit — Class II medical device recall Z-0219-2018
Terminated recall by Terumo Medical Corp, reported 2017-12-20, distributed nationwide. An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introducer Sheath wa
| Recall number | Z-0219-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Terumo Medical Corp, Somerset, NJ, United States |
| Recall initiated | 2017-06-07 |
| Classified | 2017-12-08 |
| Reported by FDA | 2017-12-20 |
| Terminated | 2019-04-25 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Reason classes | sterility, packaging |
| Lot numbers | 161110, 161214, 170119 |
Product
Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 5FR - 10CM (0.025), REF/Product Code RM*ES5J10HAT, STERILE, Rx ONLY
Reason for recall
An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introducer Sheath was detected in a small quantity of the affected lot population, 0.01% (1 in 10, 000 units). This breach of the sterile barrier may compromise the sterility of the sheath.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0219-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.