regard IV Start Kits Recall: Potential Inadequacy in Drug Kit Validation
regard recalls specific IV start kits due to potential inadequacy in validation of test methods used during manufacturing. Affected kits include certain lot numbers from 2022-2023.
Recall notice
A drug kit component was recalled by its manufacturer due to the potential for inadequacy of the validation of test methods used in its manufacture.
Contact the company
What happened, in plain English
regard has recalled specific IV start kits that may have issues with how the drug kit components were validated during manufacturing. This could affect the safety and reliability of the kits if used in medical settings. Read more at govinfonow.com/recall/60919-regard-iv-start-kits-recall-potential-inadequacy-in-drug-kit.
Source Summary by GovInfoNow · govinfonow.com/recall/60919-regard-iv-start-kits-recall-potential-inadequacy-in-drug-kit · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1005-2022
Cite this page
“regard IV Start Kits Recall: Potential Inadequacy in Drug Kit Validation.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/60919-regard-iv-start-kits-recall-potential-inadequacy-in-drug-kit. Based on FDA recall #Z-1005-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1005-2022%22&limit=1).
Why it’s dangerous
The recall states that a drug kit component was recalled due to potential inadequacy in the validation of test methods used in its manufacture. This means the quality control process might not have properly ensured the safety and accuracy of the kit components.
Who’s affected
Healthcare providers using the recalled IV start kits are most at risk. Patients receiving care with these kits could be impacted if the validation issues lead to improper drug administration.
How to tell if you have this one
Check for the item numbers 830015013 or 830084003 on the kit packaging. Look for specific lot numbers listed in the recall notice, which range from 2022 to 2023.
- Brand
regard- Category
Medical device
All 3 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 II- Status
Terminated- Distribution
US Nationwide distribution in the state of Missouri.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-1004-2022 | Convenience kits containing regard IV Start Kits: (1) regard Clinical Packaging Solutions, Item Number: 830014015, LD00199O - C Section Mother; and (2) regard Clinical Packaging Solutions, Item Number: 830014016, LD00199P - C Section Mother.; (1) Item #830014015 - Lot number 87229O, exp. 5/31/2022 (2) Item #830014016 - Lot numbers 87952P, exp. 5/31/2022; 88219P, exp 6/30/2022; 89163, exp. 6/30/2022; 89430, exp. 5/31/2022; 89926, exp. 6/30/2022; 90372, exp, 6/30/2022; 91054, exp. 12/31/2022; and 91443, exp. 5/31/2023. | 290 convenience kits |
| Z-1005-2022 | Convenience kits containing regard IV Start Kits: (1) regard Clinical Packaging Solutions, Item Number: 830015013, LD00200M - Vag Delivery Mother; and (2) regard Clinical Packaging Solutions, Item Number: 830084003, LD00866C - Vag Delivery Mother.; (1) Item Number: 830015013 - Lot numbers 87230M, exp. 5/31/2022; 87954M, exp. 5/31/2022; 88285M, exp. 5/31/2022; 88999M, exp. 6/30/2022; 89494, exp. 5/31/2022; 89985, exp. 6/30/2022; 90866, exp. 6/30/2022; and 91603, exp. 5/31/2023; and (2) Item 830084003 - Lot numbers 86155C, exp. 3/31/2022; 84799C, exp. 3/31/2022; 86735C. exp. 3/31/2022, 87269C, exp. 7/31/2022; 87871C, exp. 7/31/2022; 88564C, exp. 1/31/2023; 89260, exp. 2/28/2023; 89820, exp. 2/28/2023; 90253, exp. 1/31/2023; 90594, exp. 12/31/2022; and 91335, exp. 12/31/2022. | 1,501 convenience kits |
| Z-1006-2022 | Convenience kits containing regard IV Start Kits: regard Clinical Packaging Solutions, Item Number: 830110002, IV01121B - IV Start Labor Birth.; Lot numbers 89889, exp. 5/12/2022; 90446, exp. 5/12/2022; and 90641, exp. 5/12/2022. | 950 convenience kits |
What to do — step by step
Check Kit Details
Identify the item number and lot number on the kit packaging to determine if it is affected by this recall.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “US Nationwide distribution in the state of Missouri.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 2.4 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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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-1005-2022 (March 18, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1005-2022 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.