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U.S. Department of Health and Human Services

Class 2 Device Recall Halo Closed System Transfer Device

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  Class 2 Device Recall Halo Closed System Transfer Device see related information
Date Initiated by Firm November 22, 2016
Create Date January 11, 2017
Recall Status1 Terminated 3 on November 09, 2018
Recall Number Z-1003-2017
Recall Event ID 75810
510(K)Number K150486  
Product Classification Closed antineoplastic and hazardous drug reconstitution and transfer system - Product Code ONB
Product Halo Closed System Transfer Device, closed syringe adaptor, REF CSA100, Rx only, Sterile, packaged as individual units, packed and shipped 60 units/box and 4 boxes/shipping carton Corvida Medical, Coralville, IA 52241.
Code Information Lot 0610525, 2017-10-18
Recalling Firm/
Manufacturer		 J&J Solutions, Inc. DBA Corvida Medical
2261 Crosspark Rd Ste 127
Coralville IA 52241-4716
Manufacturer Reason
for Recall		 Product malfunction: Needle does not retract.
FDA Determined
Cause 2		 Under Investigation by firm
Action Corvida Medical sent an Urgent Notice: Medical Device Recall letter dated November 22, 2016, to all affected customers. After completing a Health Hazard Evaluation, recalling firm drafted a Recall Notification by Phone script. on November 21 2016, utilizing the script, the Vice President of Sales contacted all parties (customers) who received the recalled lot. He confirmed each customers understanding of the recall notification and forwarded the contact records to the Recall Coordinator. If you have further questions , please contact your Sales Representative or Corvida Customer Service at (800) 651-6832.
Quantity in Commerce 5520 units
Distribution US Distribution to the states of : MD, TX, and WI. There was no foreign/military/government 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 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 = ONB and Original Applicant = J & J Solutions, Inc. d/b/a/Corvida Medical
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