FDA Medical Device Recalls (openFDA)
Terumo Medical Corp: Glidesheath Slender Hydrophilic Coated Introducer Sheath, 5FR - 10CM (0.021), REF/Product Code RM*RS5F10PA, STERILE, Rx ONLY
- Recall number
- Z-0223-2018
- Recalling firm
- Terumo Medical Corp
- Product
- Glidesheath Slender Hydrophilic Coated Introducer Sheath, 5FR - 10CM (0.021), REF/Product Code RM*RS5F10PA, STERILE, Rx ONLY
- Status
- Terminated
- Initiated
- 2017-06-07
- Posted
- not on file
- Terminated
- 2019-04-25
- 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.
- Root cause
- Nonconforming Material/Component
- Action
- URGENT VOLUNTARY MEDICAL DEVICE RECALL Letters (dated June 7, 2017) and Response Forms were sent to the consignees via UPS on June 7, 2017.
- Quantity
- not on file
- Distribution
- Nationwide and Canada
- Lot, serial or model codes
- Lot s 161019, 161115, 161212, 170112
- 510(k) numbers
- ["K142183"]
- PMA numbers
- not on file
- Product code
- DYB
- Firm FEI
- 2243441
- Firm city
- Somerset
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28