Z-0222-2018 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 A-Kit, 6FR - 10CM (0.025), REF/Product Code RM*ES6J10HAT, 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 161018, 161116, 161117, 161213, 161214, 170118, 170119