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ARROW recallZ-0102-2023 · ARROW INTERNATIONAL Inc. · initiated Sep 14, 2022

Terminated

Is my device affected?

  1. 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.
  2. 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.
  3. 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

Mislabeling: the corrugate label, lidstock, banner card, and peel sticker accompanying the affected product incorrectly displays a double lumen 5.5 French catheter (and related priming volumes and kit contents for product code ASK-41552-JHVA1), instead of the packaged single-lumen 4.5 French catheter (and related priming volumes and kit contents for product code ASK-41541-JHVA1).

FDA root cause category: Under Investigation by firm

What the company is doing

The firm sent an URGENT MEDICAL DEVICE NOTFICATION to its sole consignee on 09/15/2022, by FedEx 2-day mail. The letter explained the reason for recall and requested the following: "Please adhere to the following actions: 1. Check your inventory for products in scope of this advisory notice. 2. If you do not have affected product, mark the applicable checkbox on the Acknowledgement Form (Appendix 2) and return the form to Teleflex Customer Service using the contact information below. 3. If you have affected product, mark the applicable checkbox on the Acknowledgement Form (Appendix 2), return the form to Teleflex Customer Service using the contact information below, and place a copy of this advisory notice with all affected products. Adverse reactions or quality problems experienced with the use of this product should be reported to Teleflex Customer Service using the contact information below or may also be reported to the FDA s MedWatch Adverse Event Reporting program either by phone at 1-888-INFO-FDA (1-888-463-6332) or online at https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverseevent-reporting-program. Transmission of this Advisory Notice This advisory notice should be passed on to all persons who need to be aware within your organization or to any organization where the potentially affected devices have been transferred. Please consider end users, clinicians, risk managers, supply chain/distribution centres, etc., in the circulation of this notice. Please maintain awareness of this notice until all required actions have been completed in your organization.

Recall details

Recall number
Z-0102-2023
Status
Terminated
Initiated by the company
Sep 14, 2022
Posted by the FDA
Oct 19, 2022
Recalling firm
ARROW INTERNATIONAL Inc.
Quantity
18 devices
Product code
PND
FDA submissions
K161313
Distribution
US Nationwide distribution in the state of Florida.

Product description

ARROW Pressure Injectable Arrowg+ard Blue Advance Two-Lumen Midline Kit, 5.5 Fr, 15 cm, .018 Inch dia., REF ASK-41552-JHVA1. For peripheral access to the venous system for intravenous therapy, blood sampling, infusion, and pressure injection of contrast media.

Code information (models, lots, serial numbers)

UDI (01)10801902144284(17)230731(11)220504(10)13F22C0757

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

9 devices cleared under K161313 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

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