Z-0220-2018 Class II Terminated
FDA device recall Z-0220-2018 was initiated by Terumo Medical Corp on June 7, 2017 and is designated Class II. 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).… The recall status is terminated (terminated April 25, 2019). Affected quantity: N/A.
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 (0.021), REF/Product Code RM*ES6F10HAU, 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 s161019, 161102, 161103, 161118, 161201, 161202, 161205, 161215, 161216, 170109, 170110, 170111, 170202, 17023