FDA Device recall Z-0228-2018
Glidesheath Slender Hydrophilic Coated Introducer Sheath, 6FR - 10CM (0.025), REF/Product Code RM*RS6J10PA, STERILE, Rx ONLY
- FDA Device
- Class II
- terminated
- Published 2017-12-20
On 2017-12-20 the FDA classified a Class II recall of Glidesheath Slender Hydrophilic Coated Introducer Sheath, 6FR - 10CM (0.025), REF/Product Code RM*RS6J10PA, STERILE, Rx ONLY by Terumo Medical, citing 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%….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0228-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-06-07 |
| Published | 2017-12-20 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Terumo Medical |
| Distribution | US |
Product
Glidesheath Slender Hydrophilic Coated Introducer Sheath, 6FR - 10CM (0.025), REF/Product Code RM*RS6J10PA, STERILE, Rx ONLY
Reason
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.
Identifiers
| code_info | Lot s 161115, 161130, 161207, 170116 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0228-2018%22
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