Z-1082-2015Class II

ARROWg+ard Blue PLUS Pressure Injectable Two-Lumen CVC Kit. The Multiple-Lumen Catheter permits venous access...

Name: Z-1082-2015 ARROWg+ard Blue PLUS Pressure Injectable Two-Lumen CVC Kit. The Multiple-Lumen Catheter permits venous access...
Creator: Arrow International Inc
Published: 2015-01-02
License: https://open.fda.gov/license/

Arrow International LLC (subsidiary of Teleflex Incorporated) / initiated 2015-01-02 / Terminated / root cause: manufacturing process

FDA source

Arrow International Inc began a recall of ARROWg+ard Blue PLUS Pressure Injectable Two-Lumen CVC Kit. The Multiple-Lumen Catheter permits venous access to the central circulation by way of the femoral... on 2015-01-02. FDA classified it as Class II and gives the reason as "Foreign material found within the kits. The foreign material, white or black particles and/or thread, is visible and can beidentified by the user". 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-1082-2015
Classification: Class II
Status: Terminated
Initiated: 2015-01-02
Posted: 2015-02-10
Terminated: 2016-10-25
Recalling firm: Arrow International LLC (subsidiary of Teleflex Incorporated)
Product: ARROWg+ard Blue PLUS Pressure Injectable Two-Lumen CVC Kit. The Multiple-Lumen Catheter permits venous access to the central circulation by way of the femoral jugular, or subclavian veins.
Product code: FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Reason for recall: Foreign material found within the kits. The foreign material, white or black particles and/or thread, is visible and can beidentified by the user.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: An urgent Medical Device Recall Notification, dated January 2, 2015, was sent to end users requesting they check their inventory and return affected product per Arrow's instructions.
Quantity in commerce: 1195
Distribution: Nationwide
Product codes and lots: product number CDC-42802-P1A, lot number 23F14A0063

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1082-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1082-2015	Class II	Terminated	Voluntary: Firm initiated	2015-02-18	2015-02-10

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)