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U.S. Department of Health and Human Services

Class 2 Device Recall Percutaneous Sheath Introducer Kit

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 Class 2 Device Recall Percutaneous Sheath Introducer Kitsee related information
Date Initiated by FirmMarch 20, 2017
Create DateJune 06, 2017
Recall Status1 Terminated 3 on December 18, 2018
Recall NumberZ-2293-2017
Recall Event ID 76937
510(K)NumberK002507 
Product Classification Catheter,intravascular,therapeutic,short-term less than 30 days - Product Code FOZ
ProductPercutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port for use with 7 - 7.5Fr. Catheters The Arrow Percutaneous Sheath Introducer permits venous access and catheter introduction to the central ciruclation
Code Information Material number ASK-09801-ST                  
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 initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packaged with certain Arrow products.
FDA Determined
Cause 2		Under Investigation by firm
ActionArrow International sent an Urgent Medical Device Notification Letter dated April 5, 2017, to affected customers to inform them of the issue. The notice provided safety instructions for using the product and instructed customers to return the enclosed acknowledgement form indicating the notice was received, and fax it to 855-419-8507, Attn: Customer Service or email to recalls@teleflex.com. Customers with questions were instructed to call 1-866-246-6990. For questions regarding this recall call 610-378-0131.
Quantity in Commerceunknown-firm reports total devices distributed 43,394
DistributionNationwide Distribution
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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