Z-1879-2017Class II

Pressure Injectable Arrowg+ard Blue Plus Multi-Lumen Central Venous Catheterization Kit. Permits venous...

Name: Z-1879-2017 Pressure Injectable Arrowg+ard Blue Plus Multi-Lumen Central Venous Catheterization Kit. Permits venous...
Creator: Arrow International Inc
Published: 2017-03-17
License: https://open.fda.gov/license/

Arrow International LLC (subsidiary of Teleflex Incorporated) / initiated 2017-03-17 / Terminated / root cause: manufacturing process

FDA source

Arrow International Inc began a recall of Pressure Injectable Arrowg+ard Blue Plus Multi-Lumen Central Venous Catheterization Kit. Permits venous access to central circulation by way of subclavian... on 2017-03-17. FDA classified it as Class II and gives the reason as "Arrow International is recalling due to possible voids in the catheter hub, which could lead to an interlumen crossover". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1879-2017
Classification: Class II
Status: Terminated
Initiated: 2017-03-17
Posted: 2017-04-10
Terminated: 2020-03-24
Recalling firm: Arrow International LLC (subsidiary of Teleflex Incorporated)
Product: Pressure Injectable Arrowg+ard Blue Plus Multi-Lumen Central Venous Catheterization Kit. Permits venous access to central circulation by way of subclavian, jugular and femoral veins. The ARROWg+ard technology is intended to provide protection against catheter-related bloodstream infections (CRBSIs). It is not intended to be used as a treatment for existing infections nor is it indicated for long-term use (>30 days). Clinical effectiveness of the ARROW g+ard Blue Plus catheter in preventing CRBSIs compared to the original ARROWg+ard Blue catheter has not been studied
Product code: FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Reason for recall: Arrow International is recalling due to possible voids in the catheter hub, which could lead to an interlumen crossover.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Arrow International mailed an Urgent Medical Device Notification Letter dated April 4, 2017, to affected customers to inform them of the issue. Customers were asked to discontinue use immediately and return product by completing the enclosed Recall Acknowledgement Form then emailing it to [email protected] or faxing it to 1-855-419-8507. A Customer Service Representative will provide a Return Goods Authorization Number for the products' return. For questions regarding this recall call 866-246-6990.
Quantity in commerce: 310 units
Distribution: US Distribution to NJ, IL, and PA
Product codes and lots: Product Codes ASK-45703-PRWJ1, ASK-45703-PUAB1, and ASK-45703-PUPM Lot # 13F16L0105, 23F16K0180 and 13F16L0199

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1879-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1879-2017	Class II	Terminated	Voluntary: Firm initiated	2017-05-03	2017-04-26

Product code FOZ

K071538Class IIArrow, Arrowg+ard and Arrowg+ard Blue Plus Pressure Injectable Central Venous CatheterArrow International, Inc. / cleared 2007-08-30

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)