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U.S. Department of Health and Human Services

Class 2 Device Recall Catheter Introducer

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  Class 2 Device Recall Catheter Introducer see related information
Date Initiated by Firm March 03, 2014
Date Posted March 27, 2014
Recall Status1 Terminated 3 on June 19, 2014
Recall Number Z-1301-2014
Recall Event ID 67712
510(K)Number K090999  
Product Classification Introducer, catheter - Product Code DYB
Product 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.
Code Information 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 
Recalling Firm/
Manufacturer		 Biocardia, Inc.
125 Shoreway Rd Ste B
San Carlos CA 94070-2718
For Additional Information Contact Brian McCollum
650-226-0120
Manufacturer Reason
for Recall		 Firm discovered the potential for particulates in the inner lumen of Morph Access Pro Steerable Introducer, which could result in am embolic event.
FDA Determined
Cause 2		 Other
Action The firm, BioCardia, Inc., sent an "URGENT-VOLUNTARY MEDICAL DEVICE RECALL" letter dated March 3, 2014 its customers, hospital's Director of Risk Management, via USPS mail and priority mail to Cardiac Catheterization Laboratory. The letter described the product, problem and actions to be taken. The customers were instructed to immediately examine your inventory; quarantine the product; return the product to BioCardia and contact Customer Service at 650-226-0148 to coordinate product return; in the event you no longer have this device as a result of further distribution, identify the purchaser and notify them at once of this recall; and complete and return the enclosed MEDICAL DEVICE RECALL RETURN RESPONSE Acknowledgement and Receipt Form via FAX to 650-631-3731 or mail to: BioCardia, Inc., 125 Shoreway Road, Suite B, San Carlos, CA 94070 as soon as possible. If you have any questions, call the Vice President, Quality Assurance at 650-226-0143.
Quantity in Commerce ~2541 - both models
Distribution Worldwide Distribution: US (nationwide) and country of: Israel.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = DYB and Original Applicant = BIOCARDIA, INC.
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