FDAFDA · Food and drugs·Recall number Z-1301-2014
Morph AccessPro Steerable Introducer; 6F Introducer, 45 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 MAP645 - Lot numbers: 1037 1048 1055 1059 1069 1073 1074 1079 1092 1095 1115 1118 1121 1125 1128 1130 1134 1147 1155 1164 1168 1169 1173 1177 1184 1190
- 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.