Severity
Critical
CriticalClass ITerminated
FDA Devices recall · Reported May 19, 2021
Kit: CentralLineDresChangeClrSeq MAI Kit Part Number: 79420
Medical convenience kits are being recalled due to a potential breach in the package integrity of a component, the BD ChloraPrep 3mL applicator.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Medical Action Industries, Inc. 306 recalled Kit: CentralLineDresChangeClrSeq MAI Kit Part Number: 79420 - a critical-severity action.
Kit: CentralLineDresChangeClrSeq MAI Kit Part Number: 79420 was recalled by Medical Action Industries, Inc. 306 in May 19, 2021. Reason: Medical convenience kits are being recalled due to a potential breach in the package integrity of a componen…. Check the official notice for the remedy. Verify recall #Z-1554-2021 with the FDA Devices before acting.
The recall
Medical Action Industries, Inc. 306 issued this critical-severity FDA Devices recall-Medical convenience kits are being recalled due to a potential breach in the package integrity of a componen….
- Critical
- severity level
- Class I
- classification
- May 19, 2021
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1554-2021 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1554-2021) was formally reported on May 19, 2021, with the manufacturer initiating the action on April 9, 2021. It is classified under Critical severity (Class I), with a current status of Terminated. Medical Action Industries, Inc. 306 is listed as the recalling firm, operating out of Arden, NC. Federal records list the affected scope as 30 cases (20 kits per case).
The documented reason for this recall is: Medical convenience kits are being recalled due to a potential breach in the package integrity of a component, the BD ChloraPrep 3mL applicator. Distribution data in the federal record shows the product reached: Distributed US nationwide to OH, OR, FL and CA.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
30 cases (20 kits per case)
Related Recalls
6
3 from same agency
Product description
Kit: CentralLineDresChangeClrSeq MAI Kit Part Number: 79420
Reason for recall
Medical convenience kits are being recalled due to a potential breach in the package integrity of a component, the BD ChloraPrep 3mL applicator.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Terminated |
| Recall number | Z-1554-2021 |
| Date reported | May 19, 2021 |
| Date initiated | April 9, 2021 |
| Recalling firm | Medical Action Industries, Inc. 306 |
| Firm location | Arden, NC |
| Affected scope | 30 cases (20 kits per case) |
| Distribution | Distributed US nationwide to OH, OR, FL and CA. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1554-2021) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
Kit: CentralLineDresChangeClrSeq MAI Kit Part Number: 79420. Recalled by Medical Action Industries, Inc. 306. Units affected: 30 cases (20 kits per case).
Why was this product recalled? ▼
Medical convenience kits are being recalled due to a potential breach in the package integrity of a component, the BD ChloraPrep 3mL applicator.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 19, 2021. Severity: Critical. Recall number: Z-1554-2021.
Where was the recalled product distributed? ▼
Distribution: Distributed US nationwide to OH, OR, FL and CA..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1554-2021) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
Nearby Recalls in This Category
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported May 19, 2021. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.