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U.S. Department of Health and Human Services

Class 2 Device Recall Arrow Percutaneous Sheath Introducer Kits

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  Class 2 Device Recall Arrow Percutaneous Sheath Introducer Kits see related information
Date Initiated by Firm April 14, 2014
Date Posted June 04, 2014
Recall Status1 Terminated 3 on October 14, 2016
Recall Number Z-1713-2014
Recall Event ID 68073
510(K)Number K780532  
Product Classification Introducer, catheter - Product Code DYB
Product Arrow¿ Percutaneous Sheath Introducer Kits

The Percutaneous sheath introducer products permit venous or arterial access and device introduction to the central circulation.
Code Information Product codes and lot numbers: AK-09903-A 23F13G0162 AK-09903-S RF3064511 CDC-09903-1A 23F13G0642 AK-09903-J 23F13G0400 ASK-09903-CMC RF3064673 NL-09903-S 23F13G0630 AK-09903-LFSP RF3065449 ASK-09903-CMC 23F13G0343 NR-09903-S 23F13G0180 AK-09903-S 23F13G0204 ASK-09903-NKC 23F13G0336 SI-09903-E RF3064710 AK-09903-S RF3064956 ASK-09903-TJ 23F13G0567 SI-09903-E RF3064915 AK-09903-S 23F13H0195 CDC-09903-1A RF3065316
Recalling Firm/
Arrow International Inc
2400 Bernville Road
Reading PA 19605
For Additional Information Contact Customer Support
Manufacturer Reason
for Recall
Arrow is recalling the Arrow¿ Percutaneous Sheath Introducer Kits due to dilator tip damage noted during internal inspection. Dilator tip damage has the potential to result in vessel damage.
FDA Determined
Cause 2
Process control
Action Teleflex/Arrow International sent an Urgent Medical Device Recall Notification letter dated April 17, 2014, to distributors and end users. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately discontinue use and quarantine any affected product and to complete the enclosed Recall Acknowledgement Form and fax it to 1-800-343-2935 to return product. Customers would be contacted by a customer service representative for a Return Goods Authorization (RGA) Numbers and would be provided instructions for the return of the product. Customers should complete the form whether they have affected product or not. Customers with questions were instructed to call 1-800-343-2935. For questions regarding this recall call 610-378-0131.
Quantity in Commerce 15424
Distribution Worldwide Distribution - USA (nationwide) and Canada.
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.