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 Arrow 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 Arrow Percutaneous Sheath Introducer Kit see related information
Date Initiated by Firm May 23, 2018
Create Date July 30, 2018
Recall Status1 Terminated 3 on May 20, 2020
Recall Number Z-2576-2018
Recall Event ID 80378
510(K)Number K780532  
Product Classification Percutaneous Sheath Introducer Kit - Product Code DYB
Product Percutaneous Sheath Introducer Kit for use with 7 - 7.5 Fr. Catheters (8 Fr. 10 cm sheath length .035 inch dia. spring-wire guide), REF ES-09807. The percutaneous sheath introducer permits venous access and catheter introduction to the central circulation.
Code Information Lot/Batch Number: 13F18A0037 Expiration Date/Expected Life: Apr 2019
Recalling Firm/
Manufacturer		 Arrow International Inc
2400 Bernville Rd
Reading PA 19605-9607
For Additional Information Contact Karen Boylan
866-396-2111
Manufacturer Reason
for Recall		 Product contains dry natural rubber latex. Label states Latex Free.
FDA Determined
Cause 2		 Process control
Action On May 23, 2018, Arrow International issued Urgent Medical Device Recall notices and response forms to their customer. Customers are advised to take the following actions: 1. Immediately discontinue distribution and quarantine affected product. 2. Using the provided customer letter and Recall Acknowledgement Form templates, customers who have further distributed product should contact those individuals. 3. To return affected products from your inventory, complete and return the Recall Acknowledgement Form via to 1-855-419-8507, Attn: Customer Service or email to recalls@teleflex.com. 4. If you and your customers have no affected stock, please complete and return the Recall Acknowledgment Form and fax it to 1-855-419-8507, Attn: Customer Service or email to recalls@teleflex.com. 5. If you have any other questions, feel free to contact your local sales representative or Customer Service at 1-866-396-2111.
Quantity in Commerce 60 units
Distribution Puerto Rico
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 = DYB and Original Applicant = ARROW INTL., INC.
-
-