Glidesheath Slender Hydrophilic Coated Introducer Sheath, 7FR - 10CM (0.021), REF/Product Code RM*RS7F10PA, STERILE, Rx ONLY
FDA Recall Z-0229-2018 · Posted None
Recalling FirmTerumo Medical Corp
Recall StatusTerminated
Product CodeDYB
Date Initiated2017-06-07
Date Terminated2019-04-25
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.
Firm 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.
Root Cause
Nonconforming Material/Component
Distribution Pattern
Nationwide and Canada
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.