Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 6FR - 10CM (0.021), REF/Product Code RM*ES6F10HAU, STERILE, Rx ONLY
This recall has been terminated (originally issued June 7, 2017).
- Company
- Terumo Medical Corp
- Recall Initiated
- June 7, 2017
- Terminated
- April 25, 2019
- Recall Number
- Z-0220-2018
- Firm Location
- Somerset, NJ
- Official Source
- View on FDA website ↗
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
Nationwide and Canada
Lot / Code Info
Lot s161019, 161102, 161103, 161118, 161201, 161202, 161205, 161215, 161216, 170109, 170110, 170111, 170202, 17023
Root Cause
Nonconforming Material/Component
Action Taken
URGENT VOLUNTARY MEDICAL DEVICE RECALL Letters (dated June 7, 2017) and Response Forms were sent to the consignees via UPS on June 7, 2017.
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