Z-0226-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- December 20, 2017
- Initiation Date
- June 7, 2017
- Termination Date
- April 25, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- N/A
Product Description
Glidesheath Slender Hydrophilic Coated Introducer Sheath, 6FR - 10CM (0.021), REF/Product Code RM*RS6F10PA, 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.
Distribution Pattern
Nationwide and Canada
Code Information
Lot s 161020, 161021, 161024, 161025, 161027, 161028, 161031, 161101, 161104, 101107, 101108, 161109, 161109, 161110, 161111, 161114, 161121, 161122, 161122, 161123, 161124, 161125, 161128, 161129, 161130, 161206, 161207, 161208, 161209, 161212, 161219, 161220, 161221, 161222, 1612223, 161226, 161227, 161228, 170109, 170112, 170113, 170116, 170117, 170120, 170123, 170124, 170125, 170126, 170127, 170130, 170131, 170201