Recall Z-0991-2014 ยท DYB Introducer, Catheter
Biocardia, Inc.
MORPH ACCESSPRO Steerable Introducer; 6F introducer, 90 cm working length: Sterile in unopened, undamaged pouch. Sterilized by EtO gas, Non-pyrogenic: BioCardia Inc. San Carlos, CA 94070 Intended to provide a pathway through which medical instruments such as balloon dilation catheters, guidewires and other therapeutic devices may be introduced into the peripheral vasculature.
| Date | Feb 19, 2014 (initiated Feb 7, 2014) |
| Status | Terminated |
| Reason | Tyvek packaging may be worn, causing loss of package integrity. |
| Root cause | Process control |
| Action | Sales Representative called each affected hospital on February 7, 2014, to notify them of the recall. BioCardia has initiated a recall of Morph AccessPro due to a potential compromise of the sterile barrier. Use of this product may result in patient infection. Sales representatives contacted hospital sites identified in Attachment 3 by telephone. Script provided as follows: "BioCardia has initiated a recall of Morph Access Pro due to a potential compromise of the sterile barrier. Use of this product may result in patient infection. Our records indicate that we sold you. The recall is limi |
| Quantity | 11 units |
| Distribution | US Distribution including the states of FL, MA, WY. OH, MI and KS. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K090999 | BIOCARDIA MORPH SHEATH GUIDE Biocardia, Inc., Apr 15, 2009 |