Recall Z-0464-2023— Medical Action Industries, Inc. 306
Class II · Terminated
Class II FDA medical device recall by Medical Action Industries, Inc. 306, initiated 2022-10-12, terminated 2025-03-25. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: 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..
- Recalling firm
- Medical Action Industries, Inc. 306
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2022-10-12
- Terminated
- 2025-03-25
- Firm location
- Arden, NC, United States
Product 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.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.