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U.S. Department of Health and Human Services

Class 2 Device Recall BioFlo Midline

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  Class 2 Device Recall BioFlo Midline see related information
Date Initiated by Firm May 04, 2020
Create Date June 17, 2020
Recall Status1 Open3, Classified
Recall Number Z-2396-2020
Recall Event ID 85631
Product Classification Catheter, intravascular, therapeutic, short-term less than 30 days - Product Code FOZ
Product BioFlo Midline Convenience Kits - Product Usage: These introducers are used for the percutaneous introduction of diagnostic or therapeutic devices, such as catheters or pacing leads in the vasculature.

Item Numbers
H96560M0125711
H96560M0133541
H96560M0354721
H96560M0367081
H96560M05019121
H96560M05019131
H96560M1220291
H96560M1303161
H96560M1303181
H96560M1318211
H96560M1408911
H96560M1429481
H96560M1803431
H96560M18157131
H96560M2208531
H96560M2208541
H96560M2500981
H96560M611025111
H96560M611052811
H96560M611056011
H96560M611095811
H965PKM1387818S1
H965PKM1404211S1
H965PKM1635214S1
H965PKM220533S1
H965PKM220853S1
H965PKM220855S1
H965PKM61095322S1
H965PKM61102511S1

Cat. No.
60M012571
60M013354
60M035472
60M036708
60M0501912
60M0501913
60M122029
60M130316
60M130318
60M131821
60M140891
60M142948
60M180343
60M1815713
60M220853
60M220854
60M250098
60M61102511
60M61105281
60M61105601
60M61109581
PKM1387818S
PKM1404211S
PKM1635214S
PKM220533S
PKM220853S
PKM220855S
PKM61095322S
PKM61102511S
Code Information Lots 5513075 5543988 5569542 5580342* 5488819 5513069 5555125 5569548 5454444 5469653 5503014 5505722 5463227 5468512 5480502 5502087 5519226 5530266 5546401 5552137 5569550 5488815 5580584* 5474463 5513067 5571888 5462690 5472106 5502077 5513079 5528683 5546415 5557545 5566356 5488825 5530192 5576297* 5580586* 5588914* 5468514 5478046 5491839 5496906 5500243 5536950 5574449 5587258 5564674 5470097 5470834 5477983 5482399 5532402 5536956 5567559 5571900 5578553 5543994 5588900* 5574116 5477356 5479479 5492926 5497561 5542304 5550981 5504522 5542305 5584024 5584039 5470195 5472104 5477938 5505005 5523169 5528676 5534740 5539980 5498245 5564682 5571896* 5580582* 5587276* 5468492 5470191 5472098 5488811 5505003 5532394 5536962 5557555 5567546 5587263* 5501851 5501853 5470197 5480508 5500249 5504999 5523173 5546417 5566339 5530185 5519216 5523155 5526006 5536958 5559207 5585529* 5587815* 5560886 5513081 5539976 5589180* 5557537 5548425 5505070 5481670 5486489 5536936 5504526 5504527 5477373 5586746 *All units of these lots are within AngioDynamics control (US and OUS Inventory) and not distributed, therefore, removed from recall notification.
Recalling Firm/
Manufacturer
Angiodynamics, Inc.
603 Queensbury Ave
Queensbury NY 12804-7619
For Additional Information Contact David Greer
518-795-1676
Manufacturer Reason
for Recall
Certain AngioDynamics PICC Kits contain BD PosiFlush SF Saline Flush Syringes which were recalled by BD Medical on April 16, 2020.
FDA Determined
Cause 2
Process control
Action The firm distributed URGENT VOLUNTARY MEDICAL DEVICE RECALL letters to affected customers on May 4, 2020. Customers were instructed to segregate and return affected devices to AngioDynamics, and to complete and return the reply verification tracking form provided with the recall notification. If affected product is located in your institution, please call AngioDynamics Customer Service at 1-800-772-6446 between 8:00 a.m. and 7:00 p.m. (Monday  Friday: Eastern Standard Time) to obtain a replacement or credit for your returned product. The letter included instructions on packaging and returning the recalled product.
Quantity in Commerce 119723 eaches total
Distribution US Nationwide distribution.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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