FDAFDA · Food and drugs·Recall number Z-1302-2014
Morph AccessPro Steerable Introducer; 6F Introducer, 90 cm working length: Single use only. BioCardia, Inc. San Carlos, CA 94070 BioCardia Morph AccessPro is intended to provide a pathway through medical instruments cush as balloon dilation catheters, guidewires or other therapeutic devices that may be introduced into the peripheral vasculature.
Published April 2, 2014 · Recall initiated: March 3, 2014
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
Firm discovered the potential for particulates in the inner lumen of Morph Access Pro Steerable Introducer, which could result in am embolic event.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Biocardia, Inc.
- Distributor
- Worldwide Distribution: US (nationwide) and country of: Israel.
- Lot
- Catalog number MAP690 -lot numbers: 1051 1063 1083 1106 1119 1137 1138 1140 1146 1148 1151 1154 1160 1162 1183 1186
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.