Medical Action Industries Inc. Port Access Kit, REF #76511B (on case label), sterile; and Medical Action Industries Inc.

FDA device recall Z-0464-2023 · posted 2022-12-08 · Terminated

Recall details

Recalling firm

Medical Action Industries, Inc. 306

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.

Action taken

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.

Root cause

Employee error

Status

Terminated

Product code

OWL

Quantity affected

24 cases (480 kits)

Distribution

Distribution was made to MN. There was no foreign/government/military distribution.

Date initiated

2022-10-12

Date posted

2022-12-08

Date terminated

2025-03-25

Location

Arden, NC