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U.S. Department of Health and Human Services

Class 2 Device Recall ArrowClarke" PleuraSeal Thoracentesis Kit

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  Class 2 Device Recall ArrowClarke" PleuraSeal Thoracentesis Kit see related information
Date Initiated by Firm October 24, 2017
Create Date April 03, 2018
Recall Status1 Terminated 3 on April 17, 2020
Recall Number Z-1298-2018
Recall Event ID 79294
510(K)Number K870572  
Product Classification Kit, surgical instrument, disposable - Product Code KDD
Product ArrowClarke" PleuraSeal¿ Thoracentesis Kit
Code Information AK01000 AK-01000-J AK-01000-T ASK-01000-CHP
Recalling Firm/
Manufacturer		 Arrow International Inc
2400 Bernville Rd
Reading PA 19605-9607
For Additional Information Contact
610-378-0131
Manufacturer Reason
for Recall		 Product packaging may not be completely sealed.
FDA Determined
Cause 2		 Component design/selection
Action On October 24, 2017 and Urgent Medical Device Recall letter was issued to customers to review inventory and if there's any affected stock, to immediately discontinue use, quarantine and prepare to return to recalling firm. Questions or concerns can be directed to 1-855-419-8507 or 1-866-246-6990
Distribution Nationally
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 = KDD and Original Applicant = ARROW INTL., INC.
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