Medical Action Industries, Inc. 306 Recall 91065
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.
Medical Action Industries, Inc. 306 Recall 91065 Information
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | Z-0464-2023 |
Event ID | 91065 |
Event 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. |
Product Type | Devices |
Distribution | Distribution was made to MN. There was no foreign/government/military distribution. |
Quantity | 24 cases (480 kits) |
Recall 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. |
Device Classification | 20221214 |
Device Code Info | 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. |
Center Classification Date | 20221208 |
Recall Initiation Date | 20221012 |
Recalling Firm | Medical Action Industries, Inc. 306 |
Initial Notification | Letter |
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