Recall Z-0991-2014
Biocardia, Inc. · initiated February 7, 2014
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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.
Codes / lots: Catalog number MAP690; Lot numbers 01162 and 01186.
Reason for recall
Tyvek packaging may be worn, causing loss of package integrity.
FDA-determined 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.
Details
- Recall number
- Z-0991-2014
- Initiated
- February 7, 2014
- Posted by FDA
- February 19, 2014
- Terminated
- April 3, 2014
- Product code
- DYB – Introducer, Catheter
- Quantity
- 11 units
- Distribution
- US Distribution including the states of FL, MA, WY. OH, MI and KS.
- Recalling firm
- Biocardia, Inc., San Carlos, CA