Z-2170-2017Class II

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

Name: Z-2170-2017 Arrow(R) VPS(R) Access Kit for use with 4 and 5 Fr. Peripherally Inserted Central Venous Catheters
Creator: Arrow International Inc
Published: 2017-04-28
License: https://open.fda.gov/license/

Arrow International LLC (subsidiary of Teleflex Incorporated) / initiated 2017-04-28 / Terminated

FDA source

Arrow International Inc began a recall of Arrow(R) VPS(R) Access Kit for use with 4 and 5 Fr. Peripherally Inserted Central Venous Catheters on 2017-04-28. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2170-2017
Classification: Class II
Status: Terminated
Initiated: 2017-04-28
Posted: 2017-05-26
Terminated: 2018-08-03
Recalling firm: Arrow International LLC (subsidiary of Teleflex Incorporated)
Product: Arrow(R) VPS(R) Access Kit for use with 4 and 5 Fr. Peripherally Inserted Central Venous Catheters
Product code: OBJ Catheter, Ultrasound, Intravascular
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 root cause: 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
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2170-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2170-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-07	2017-05-26

Product code OBJ

K103255Class IIVascular Positioning System Tm (Vps Tm System) StyletVasonova, Inc. / cleared 2011-02-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)