Z-1152-2018Class II

ARROWg+ard Blue PLUS catheter, Catalog Number: ASK-45854-NG

Name: Z-1152-2018 ARROWg+ard Blue PLUS catheter, Catalog Number: ASK-45854-NG
Creator: Arrow International Inc
Published: 2017-12-21
License: https://open.fda.gov/license/

Arrow International LLC (subsidiary of Teleflex Incorporated) / initiated 2017-12-21 / Terminated / root cause: manufacturing process

FDA source

Arrow International Inc began a recall of ARROWg+ard Blue PLUS catheter, Catalog Number: ASK-45854-NG Product Usage: The ARROWg+ard Blue PLUS catheter permits venous access to central circulation by... on 2017-12-21. FDA classified it as Class II and gives the reason as "Certain lots may be missing information at the bottom of the lid including the lot number, expiration date, and Unique Device Identification (UDI) information". 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-1152-2018
Classification: Class II
Status: Terminated
Initiated: 2017-12-21
Posted: 2018-03-21
Terminated: 2020-04-20
Recalling firm: Arrow International LLC (subsidiary of Teleflex Incorporated)
Product: ARROWg+ard Blue PLUS catheter, Catalog Number: ASK-45854-NG Product Usage: The ARROWg+ard Blue PLUS catheter 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 ARROWg+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: Certain lots may be missing information at the bottom of the lid including the lot number, expiration date, and Unique Device Identification (UDI) information.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Arrow International sent Notification letters to DISTRIBUTORS that include the following instructions: 1. Discontinue distribution and quarantine any affected products. 2. Inspect affected products to identify whether they have the lot number, expiration date, and UDI information. Products missing this information should be returned. 3. Using the provided Customer Letter and Acknowledgement Form templates, communicate this recall to any customers who have received affected products. Customers should return mislabeled products. Products that are properly labeled should not be returned. 4. Any customers with mislabeled products should return them with a completed Acknowledgement Form. 6. If you and customers have no affected stock please complete and return the Acknowledgment Form. Notification letters to RISK MANAGERS include the following instructions: 1. Discontinue use and quarantine any affected products. 2. Inspect affected products and identify whether they have the lot number, expiration date, and UDI information. Products missing this information should be returned to the Distributor. 3. Complete the Acknowledgement Form whether or not there is affected product that must be returned. For questions contact your local sales representative or Customer Service at 1-866-246-6990.
Quantity in commerce: 420
Distribution: United States in the state of FL.
Product codes and lots: Lot Numbers: 23F16H0744, 23F16J0072, 23F17B0781

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1152-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1152-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-28	2018-03-21

Product code FOZ

K993691Class IIArrowg +Ard Blue Plus Antimicrobial Multi-Lumen Central Venous CatheterArrow Intl., Inc. / cleared 2000-03-08

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)