ARROWg+ard Blue PLUS catheter, Catalog Number: ASK-45854-NG recallZ-1152-2018 · Arrow International Inc · initiated Dec 21, 2017
Class II Terminated All recalls posted in March 2018
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Arrow International Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Certain lots may be missing information at the bottom of the lid including the lot number, expiration date, and Unique Device Identification (UDI) information.
FDA root cause category: Process control
What the company is doing
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.
Recall details
- Recall number
- Z-1152-2018
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Dec 21, 2017
- Posted by the FDA
- Mar 21, 2018
- Recalling firm
- Arrow International Inc
- Quantity
- 420
- Product code
- FOZ
- FDA submissions
- K993691
- Distribution
- United States in the state of FL.
Product description
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.
Code information (models, lots, serial numbers)
Lot Numbers: 23F16H0744, 23F16J0072, 23F17B0781
Other devices under the same FDA submission
14 devices cleared under K993691 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- ARROW IPN037069Teleflex Incorporated · Catheter,intravascular,therapeutic,short-term less than 30 days1 recall0 reports
- ARROW IPN037833Teleflex Incorporated · Catheter,intravascular,therapeutic,short-term less than 30 days1 recall0 reports
- ARROW IPN037836Teleflex Incorporated · Catheter,intravascular,therapeutic,short-term less than 30 days1 recall0 reports
- ARROW IPN038392Teleflex Incorporated · Catheter, intravascular, therapeutic, short-term less than 30 days1 recall0 reports
- ARROW IPN055804Teleflex Incorporated · Catheter, intravascular, therapeutic, short-term less than 30 days1 recall0 reports
- ARROW IPN916999Teleflex Incorporated · Catheter, intravascular, therapeutic, short-term less than 30 days1 recall0 reports
- ARROW IPNB00080Teleflex Incorporated · Catheter, intravascular, therapeutic, short-term less than 30 days1 recall0 reports
- ARROW IPN030243Teleflex Incorporated · Catheter, intravascular, therapeutic, short-term less than 30 days20 reports
- ARROW IPN030195Teleflex Incorporated · Catheter,intravascular,therapeutic,short-term less than 30 days3 reports
- ARROW IPN030240Teleflex Incorporated · Catheter,intravascular,therapeutic,short-term less than 30 days1 report
- ARROW IPN030231Teleflex Incorporated · Catheter, intravascular, therapeutic, short-term less than 30 days1 report
- ARROW IPN037089Teleflex Incorporated · Catheter,intravascular,therapeutic,short-term less than 30 days1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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