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U.S. Department of Health and Human Services

Class 2 Device Recall Arrow VPS Access Kit

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  Class 2 Device Recall Arrow VPS Access Kit see related information
Date Initiated by Firm April 28, 2017
Create Date May 26, 2017
Recall Status1 Terminated 3 on August 03, 2018
Recall Number Z-2170-2017
Recall Event ID 77163
510(K)Number K103255  
Product Classification Catheter, ultrasound, intravascular - Product Code OBJ
Product Arrow(R) VPS(R) Access Kit for use with 4 and 5 Fr. Peripherally Inserted Central Venous Catheters
Code Information ASK-04001-DU9 and ASK-04001-DU10 Device Listing Number D156491 Lot Numbers: 23F15L0593 23F16A0300 23F16B0028 23F16B0523 23F16J0151 23F16K0363 23F16K0431 23F16K0820 23F15L0662 23F16A0298 23F16B0338 23F16C0321 23F16C0632 23F16J0105 23F16K0449
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 is notifying each customer who received the affected that product that the kits do not contain important information regarding the 3M Tegaderm CHG Chlorhexidine Gluconate I.V. Securement Dressing.
FDA Determined
Cause 2		 Unknown/Undetermined by firm
Action Arrow International sent an Urgent Medical Device Notification letter dated May 2, 2017, to all affected customers to inform them of the issue. The letter will instruct the distributor to notify their customers if the product was further distributed and to return a completed acknowledgement form indicating the amount of units on hand. For further questions, please call (610) 378-0131.
Quantity in Commerce 3,918 units
Distribution US Distribution to the state of : NC
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 = OBJ and Original Applicant = VASONOVA INC.
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