Class 2 Device Recall Port Access Kit

• Date Initiated by Firm: October 12, 2022
• Date Posted: December 08, 2022
• Recall Status: Terminated on March 25, 2025
• Recall Number: Z-0464-2023
• Recall Event ID: 91065
• Product Classification: Peripheral catheter insertion kit - Product Code OWL
• Product: Medical Action Industries Inc. Port Access Kit, REF #76511B (on case label), sterile; and Medical Action Industries Inc. IV Start Kit, REF #78019 (on kit label), sterile. Kit components are the Port Access Kit.
• Code Information: Port Access Kit case label - Lot 294281, exp. 9/28/2023, UDI #1080916018095. IV Start Kit label - Lot 294589, exp. 12/20/2024, UDI #20809160195991.
• FEI Number: 1030451
• Recalling Firm/ Manufacturer: Medical Action Industries, Inc. 306; 25 Heywood Rd; Arden NC 28704-9302
• Manufacturer Reason for Recall: The Port Access Kits were incorrectly labeled as IV Start Kits on the kit label. The case label was correctly labeled as Port Access Kits.
• FDA Determined Cause: Employee error
• Action: The recalling firm issued a letter dated 10/12/2022 to their only consignee via email on 10/12/2022. The letter informed the consignee the kits were incorrectly labeled as reference number 78019, the IV Start Kit, but the case label correctly lists the item as the Port Access Kit. The consignee was requested to review their inventory and segregate and quarantine all affected kits labeled as IV Start Kit, lot #294589. If any of the affected kits were further distributed, the consignee was requested to ensure all end users were appropriately notified of the recall. The consignee was to contact the firm for return of the affected kits. A Field Action Response Form was enclosed for completion and return to the firm via email to indicate they have read and understood the recall instructions, checked their inventory, indicated how much was in inventory, and have notified appropriate staff and customers of the recall.
• Quantity in Commerce: 24 cases (480 kits)
• Distribution: Distribution was made to MN. There was no foreign/government/military distribution.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.