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U.S. Department of Health and Human Services

Class 2 Device Recall Catheter introducer

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 Class 2 Recall
Catheter introducer
see related information
Date Posted February 19, 2014
Recall Status1 Terminated on April 03, 2014
Recall Number Z-0991-2014
Recall Event ID 67492
Premarket Notification
510(K) Number
K090999 
Product Classification Introducer, Catheter - Product Code DYB
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.
Code Information Catalog number MAP690; Lot numbers 01162 and 01186.
Recalling Firm/
Manufacturer
Biocardia, Inc.
125 Shoreway Rd Ste B
San Carlos, California 94070-2718
For Additional Information Contact Michael Kolber
650-226-0133
Manufacturer Reason
for Recall
Tyvek packaging may be worn, causing loss of package integrity.
FDA Determined
Cause 2
PRODUCTION CONTROLS: 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 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.
Quantity in Commerce 11 units
Distribution US Distribution including the states of FL, MA, WY. OH, MI and KS.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = DYB and Original Applicant = BIOCARDIA, INC.
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