Z-0179-2018Class II

Arrow(R) VPS(R) Access Kit for use with 4 Fr. Peripherally Inserted Central Venous Catheter The intended use...

Name: Z-0179-2018 Arrow(R) VPS(R) Access Kit for use with 4 Fr. Peripherally Inserted Central Venous Catheter The intended use...
Creator: Arrow International Inc
Published: 2017-06-01
License: https://open.fda.gov/license/

Arrow International LLC (subsidiary of Teleflex Incorporated) / initiated 2017-06-01 / Terminated

FDA source

Arrow International Inc began a recall of Arrow(R) VPS(R) Access Kit for use with 4 Fr. Peripherally Inserted Central Venous Catheter The intended use of the VPS Stylet and Console (VPS System) is to... on 2017-06-01. FDA classified it as Class II and gives the reason as "There is a possibility that the finished good kits may contain 5 Fr peel-away sheaths instead of the required 4 Fr peel-away sheaths". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0179-2018
Classification: Class II
Status: Terminated
Initiated: 2017-06-01
Posted: 2017-11-28
Terminated: 2020-04-13
Recalling firm: Arrow International LLC (subsidiary of Teleflex Incorporated)
Product: Arrow(R) VPS(R) Access Kit for use with 4 Fr. Peripherally Inserted Central Venous Catheter The intended use of the VPS Stylet and Console (VPS System) is to quickly and accurately guide market available peripherally inserted central catheters (PICCs) to the goal location which is to the cavo-atrial junction near the sino-atrial node
Product code: OBJ Catheter, Ultrasound, Intravascular
Reason for recall: There is a possibility that the finished good kits may contain 5 Fr peel-away sheaths instead of the required 4 Fr peel-away sheaths.
FDA root cause: Mixed-up of materials/components
Action: Arrow International sent an Urgent Medical Device Recall Notification letter dated June 1, 2017, and Recall Acknowledgement Form to their domestic consignees via FedEx 2-day. Customers were advised to immediately inspect stock, discontinue use and quarantine any products with the product codes and lot numbers listed, so that the affected products can be returned to Arrow. To return product, complete the enclosed Recall Acknowledgement Form and fax it to 1-855-419-8507, Attn: Customer Service or email to [email protected]. This will allow the firm to document the amount of product you have on hand for return. A customer service representative will the customer with a Return Goods Authorization (RGA) Number and will provide instructions for the return of products to Arrow International. If you have no affected stock, please complete the enclosed Recall Acknowledgment Form and fax it to 1-855-419-8507, Attn: Customer Service or email to [email protected]. This will allow the company to document your receipt of the letter. Customers that have any questions can contact their local sales representative or Customer Service at 1-866-246-6990.
Distribution: Nationwide Distribution to AZ, CA, MA, MO, NC, NY, OR & SD
Product codes and lots: Lot/Batch Numbers: 23F16M0017

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0179-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0179-2018	Class II	Terminated	Voluntary: Firm initiated	2017-12-06	2017-11-28
Z-0180-2018	Class II	Terminated	Voluntary: Firm initiated	2017-12-06	2017-11-28
Z-0181-2018	Class II	Terminated	Voluntary: Firm initiated	2017-12-06	2017-11-28
Z-0182-2018	Class II	Terminated	Voluntary: Firm initiated	2017-12-06	2017-11-28

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)