Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Percutaneous Sheath Introducer Kit

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall Percutaneous Sheath Introducer Kit see related information
Date Initiated by Firm March 20, 2017
Create Date June 06, 2017
Recall Status1 Terminated 3 on December 18, 2018
Recall Number Z-2293-2017
Recall Event ID 76937
510(K)Number K002507  
Product Classification Catheter,intravascular,therapeutic,short-term less than 30 days - Product Code FOZ
Product Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port for use with 7 - 7.5¿¿Fr. 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
Action Arrow 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 Commerce unknown-firm reports total devices distributed 43,394
Distribution 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 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 = FOZ and Original Applicant = ARROW INTL., INC.
-
-