Kit: Central Line Dres Change 20/Cs recallZ-0147-2022 · Medical Action Industries, Inc. 306 · initiated Sep 8, 2021
Class II Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Medical Action Industries, Inc. 306 or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
The ChloraPrep 3ml kit component has a shorter expiry date than the labeled kit expiry date.
FDA root cause category: Process control
What the company is doing
A customer email was sent to the impacted distributor dated 09/16/2021. The distributor was notified of the recall issue and instructed to inventory and segregate affected product. Warning labels were provided and are to be affixed to the affected kits. Relabeling should be conducted in a manner that does not allow other pertinent labeling information to be covered up. The distributor was also notified that the recall should be carried out to the end user level.
Recall details
- Recall number
- Z-0147-2022
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Sep 8, 2021
- Recalling firm
- Medical Action Industries, Inc. 306
- Quantity
- 42 cases
- Product code
- PEZ
- Distribution
- Distribution to a single US distributor in Michigan
Product description
Kit: Central Line Dres Change 20/Cs
Code information (models, lots, serial numbers)
Product Code: 59815B, Batch 0000285665; Kit expiration date 03/31/2024 UDI: 20809160170523
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Medical Action Industries 59816BMedical Action Industries Inc. · Central venous catheter dressing change kit1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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