Medical Action Industries LVAD Dressing Change Kit Recall: Potential Package Integrity
Medical Action Industries recalls LVAD dressing change kit (part 79544B) due to potential breach in BD ChloraPrep 3mL applicator packaging. Affected units were sold with specific lot numbers and expiration dates.
Lower-risk recall
Medical convenience kits are being recalled due to a potential breach in the package integrity of a component, the BD ChloraPrep 3mL applicator.
Contact the company
What happened, in plain English
Medical Action Industries is recalling their LVAD dressing change kits because the packaging for the BD ChloraPrep 3mL applicator might be compromised. This could lead to contamination or infection risks for patients using the kits. Read more at govinfonow.com/recall/62803-medical-action-industries-lvad-dressing-change-kit-recall-potential-package.
Source Summary by GovInfoNow · govinfonow.com/recall/62803-medical-action-industries-lvad-dressing-change-kit-recall-potential-package · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1557-2021
Cite this page
“Medical Action Industries LVAD Dressing Change Kit Recall: Potential Package Integrity.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62803-medical-action-industries-lvad-dressing-change-kit-recall-potential-package. Based on FDA recall #Z-1557-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1557-2021%22&limit=1).
Why it’s dangerous
The BD ChloraPrep 3mL applicator's packaging may have a breach that could allow contamination. This could lead to infection or other complications if the applicator is used without proper sterility.
Who’s affected
Patients using LVAD (left ventricular assist device) dressing change kits manufactured by Medical Action Industries. Those with the specific part number 79544B are most at risk.
How to tell if you have this one
Check for the part number 79544B on the kit. The kit was sold with lot number 0000282089 and expired February 12, 2022.
- Brand
Medical Action Industries- Category
Medical device
All 6 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class I- Status
Terminated- Distribution
Distributed US nationwide to OH, OR, FL and CA.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-1554-2021 | Kit: CentralLineDresChangeClrSeq MAI Kit Part Number: 79420; Kit Number: 79420; UDI (GTIN): 20809160247775; Lot Number: 0000276767 (Expiration Date: 01/31/2022), 0000278361 (Expiration Date: 05/31/2022), and 0000281458 (Expiration Date: 08/31/2022) | 30 cases (20 kits per case) |
| Z-1555-2021 | Kit: Injection REVIEW MAI Kit Part Number: 74736; Kit Number: 74736; UDI (GTIN): 20809160023720; Lot Number: 0000266521 (Expiration Date: 02/28/2022) | 9 cases (20 kits per case) |
| Z-1556-2021 | Kit: Midline Insertion DA. MAI Kit Part Number: 77981B; Kit Number: 77981B; UDI (GTIN): 20809160284053; Lot Number: 0000281502 (Expiration Date: 04/08/2022), 0000282039 (Expiration Date: 04/08/2022), 0000274390 (Expiration Date: 07/09/2021), and 0000279101 (Expiration Date: 11/13/2021) | 110 cases (5 kits per case) |
| Z-1557-2021 | Kit: LVAD Dres Chg. MAI Kit Part Number: 79544B; Kit Number: 79544B; UDI (GTIN): 20809160341855; Lot Number: 0000282089 (Expiration Date: 02/12/2022) | 10 cases (20 kits per case) |
| Z-1558-2021 | Kit: Blood Culture. MAI Kit Part Number: 80315D; Kit Number: 80315D; UDI (GTIN): 20809160186074; Lot Number: 0000280007 (Expiration Date: 07/31/2021), 0000280289 (Expiration Date: 06/30/2021), 0000279599 (Expiration Date: 05/31/2021), and 0000280554 (Expiration Date: 06/30/2021) | 205 cases (20 kits per case) |
| Z-1559-2021 | Kit: Blood Culture MAI Kit Part Number: 80076; Kit Number: 80076; UDI (GTIN): 20809160021269; Lot Number: 0000280292 (Expiration Date: 07/31/2021), 0000280766 (Expiration Date: 07/31/2021), 0000281206 (Expiration Date: 07/31/2021), 0000279153 (Expiration Date: 05/31/2021), and 0000280969 (Expiration Date: 06/30/2021) | 129 cases (20 kits per case) |
What to do — step by step
Check Kit Details
Verify the part number on the kit label to confirm if it matches 79544B.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 4 states.
FDA distribution: “Distributed US nationwide to OH, OR, FL and CA.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: California, Florida, Ohio, Oregon.
Recall timeline
FDA terminated this recall 2.5 years after the firm started it.
- Firm started the recall
- FDA classified it Class I
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
Is this recall dangerous?
The recall is for potential packaging breaches that could lead to contamination risks, but the hazard level is low risk as the remedy does not require immediate stop-use.
Similar recalls
Latest medical device recalls
Keep exploring
Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-1557-2021 (April 9, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1557-2021 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.