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U.S. Department of Health and Human Services

Class 2 Device Recall ARROW MAC TwoLumen Central Venous Access Kit

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 Class 2 Device Recall ARROW MAC TwoLumen Central Venous Access Kitsee related information
Date Initiated by FirmMay 09, 2017
Create DateJune 12, 2017
Recall Status1 Terminated 3 on September 17, 2018
Recall NumberZ-2335-2017
Recall Event ID 77232
510(K)NumberK002507 
Product Classification Catheter,intravascular,therapeutic,short-term less than 30 days - Product Code FOZ
ProductArrow MAC Two-Lumen Central Venous Access Kit Introducer Catheter The Arrow Two-Lumen Central Venous Access device permits venous access and catheter introduction to the central circulation
Code Information Material number: CDC-11242-1A Device Listing D025760
Recalling Firm/
Manufacturer		 Arrow International Inc
2400 Bernville Rd
Reading PA 19605-9607
For Additional Information Contact
610-378-0131
Manufacturer Reason
for Recall		Arrow International is recalling the affected product because the packaging may not be completely sealed, which may compromise sterility.
FDA Determined
Cause 2		Packaging
ActionArrow International sent an Urgent Medical Device Recall Notification Letter dated May 11, 2017, to affected customers. The firm's notification letter is requesting that customers immediately assess their current inventory and to discontinue and quarantine any product with the specific lot codes listed in the letter. In addition, customers were asked to complete the Recall Acknowledgement form and fax or email it back to Customer Service so they can receive a Returns Good Authorization Number for the product's return. Customers with questions were instructed to contact their local sales representative or Customer Service at 1-866-246-6990.
Quantity in Commerce27,485 units distributed in U.S., 4,371 units distributed internationally
DistributionWorldwide Distribution - US (nationwide) and Canada
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = FOZ
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