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U.S. Department of Health and Human Services

Class 2 Device Recall Central Venous Catheterization Kit w Blue FlexTip Catheter

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 Class 2 Device Recall Central Venous Catheterization Kit w Blue FlexTip Cathetersee related information
Date Initiated by FirmOctober 17, 2017
Date PostedFebruary 20, 2018
Recall Status1 Terminated 3 on April 14, 2020
Recall NumberZ-0657-2018
Recall Event ID 79197
510(K)NumberK862056 
Product Classification Catheter, percutaneous - Product Code DQY
ProductCentral Venous Catheterization Kit with Blue FlexTip Catheter; Product code: AK-04301; Exp. Dates Feb 2018 - Nov 2018
Code Information Lot number: 13F17C0501
Recalling Firm/
Manufacturer
Arrow International Inc
2400 Bernville Rd
Reading PA 19605-9607
For Additional Information ContactKaren Boylan
610-378-0131
Manufacturer Reason
for Recall
These finished good kits may contain the incorrect Springwire Guide (SWG).
FDA Determined
Cause 2
Process control
ActionOn October 17, 2017 an Urgent Medical Device recall letter from Arrow International was issued to customers requesting that customers review their inventory for product, which should immediately be discontinued and quarantined. The products are then to be returned to the firm. Questions or concerns can be directed to: Customer Service at 18662466990.
Quantity in Commerce5,926 total
DistributionDistribution US Nationwide
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 = DQY
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