Arrow Arterial Kits and Trays as follows: (1) Arrow Arterial Access Tray with 0.025" Spring-Wire Guide (Catheter Not Inc

FDA device recall Z-3299-2024 · posted 2024-09-26 · Open, Classified

Recall details

Recalling firm

ARROW INTERNATIONAL Inc.

Reason for recall

Reports have been received regarding open seals on the packaging.

Action taken

The recalling firm issued letters dated July-2024 via Fed Ex 2-day mail on 7/26/2024. The letter provided a description of the problem and immediate actions required. Medical facilities were requested to immediately check their inventory for the affected product and cease use and distribution of it. The product is to be quarantined immediately. If the facility has the impacted product, they are to indicate so on the Acknowledgement Form enclosed with the letter and FAX it to the firm. A customer service representative will contact the medical facility with a Return Goods Authorization (RGA) Number and provide instructions for the return of the product. Distributors are requested to provide the field safety notice to all customers who have received the impacted product. Each of the distributor's customers are required to complete the Acknowledgment Form and return it to the distributor. Additionally, the distributor is to check their inventory for the impacted product, cease use and distribution of it, and quarantine it. If the product has been further distributed outside of the distributor's country, they are to notify Teleflex Customer Service by return email.

Root cause

Nonconforming Material/Component

Status

Open, Classified

Product code

DQX

Quantity affected

14,845 kits

Distribution

US Nationwide distribution in the states of CA, FL, GA, IL, MA, ME, MI, NC, NY, PA, and WV. There was government distribution.

Date initiated

2024-07-26

Date posted

2024-09-26

Location

Morrisville, NC

Related 510(k) clearances