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.
Recall
- Recall Number
- Z-0464-2023
- Event Number
- 91065
- Firm
- Medical Action Industries, Inc.
- FEI Number
- 1030451
- Product Code
- OWL
- Status
- Terminated
- Root Cause
- Employee error
- Initiated
- October 12, 2022
- Posted
- December 8, 2022
- Terminated
- March 25, 2025
- Address
- 306 25 Heywood Rd, Arden, NC, 28704-9302
Description
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.
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.
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.
Distribution was made to MN. There was no foreign/government/military distribution.
24 cases (480 kits)