FDAFDA · Food and drugs·Recall number Z-0230-2018
Glidesheath Slender Hydrophilic Coated Introducer Sheath, 7FR - 16CM (0.021), REF/Product Code RM*RS7F16PA, STERILE, Rx ONLY
Published December 20, 2017 · Recall initiated: June 7, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Terumo Medical Corp
- Distributor
- Nationwide and Canada
- Lot
- Lot s 161019, 161108, 161215, 170112, 170213, 170314
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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