FDAClass IIJune 7, 2017

Arrow(R) VPS(R) Access Kit for use with 4 and 5 Fr. recall

Arrow(R) VPS(R) Access Kit for use with 4 and 5 Fr. Peripherally Inserted Central Venous Catheters

Why was Arrow(R) VPS(R) Access Kit for use with 4 and 5 Fr. recalled?

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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
Arrow(R) VPS(R) Access Kit for use with 4 and 5 Fr. Peripherally Inserted Central Venous Catheters
Recalling firm
Arrow International Inc
Quantity
3,918 units
Distribution
US Distribution to the state of : NC
Recall date
June 7, 2017
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls