ARROW Pressure Injectable Arrowg+ard Blue Advance Two-Lumen Midline Kit, 5.5 Fr, 15 cm, .018 Inch dia., REF ASK-41552-JH

FDA device recall Z-0102-2023 · posted 2022-10-19 · Terminated

Recall details

Recalling firm

ARROW INTERNATIONAL Inc.

Reason for recall

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).

Action taken

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.

Root cause

Under Investigation by firm

Status

Terminated

Product code

PND

Quantity affected

18 devices

Distribution

US Nationwide distribution in the state of Florida.

Date initiated

2022-09-14

Date posted

2022-10-19

Date terminated

2024-01-19

Location

Morrisville, NC

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