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.
This recall has been terminated (originally issued February 19, 2014).
- Company
- Biocardia, Inc.
- Recall Initiated
- February 7, 2014
- Posted
- February 19, 2014
- Terminated
- April 3, 2014
- Recall Number
- Z-0991-2014
- Quantity
- 11 units
- Firm Location
- San Carlos, CA
- Official Source
- View on FDA website ↗
Reason for Recall
Tyvek packaging may be worn, causing loss of package integrity.
Distribution
US Distribution including the states of FL, MA, WY. OH, MI and KS.
Lot / Code Info
Catalog number MAP690; Lot numbers 01162 and 01186.
Root Cause
Process control
Action Taken
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 limited to these units in this lot sold to you. We would like to confirm if you still have the unit(s). If you do, we ask that you quarantine the unit(s) and our customer service department will contact you to coordinate the return of the unit(s)." For further questions please call (650) 226-0133.