Device product
Glidesheath Slender Hydrophilic Coated Introducer Sheath, 6FR - 10CM (0.021), REF/Product Code RM*CS6F10NA, STERILE, Rx ONLY
Z-0215-2018
Product summary
- Event
- Event 77661
- Status
- Terminated
- Classification
- Class II
- Quantity
- N/A
- Official record key
device-enforcement:Z-0215-2018
Official wording
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.
Code information: Lots 161116, 170113
Distribution pattern: Nationwide and Canada
Derived failure modes
-
Labeling or packaging
incomplete seal
-
Sterility assurance
breach of the sterile barrier