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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Surgical Equipment

Medical Action Industries, Inc. 306: IV Start Kits Recalled Due to Compromised Saline Flush Syringes

Agency Publication Date: March 28, 2024
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Summary

Medical Action Industries, Inc. 306 is recalling approximately 206,200 IV Start Kits because they contain saline flush syringes that were previously recalled by the original supplier. These sterile kits are used in clinical settings to initiate intravenous therapy, and the inclusion of a defective syringe may compromise the safety of the procedure. Consumers and healthcare providers should check their inventory for specific lot numbers distributed in Minnesota and North Dakota.

Risk

The saline flush syringes included in these kits have been recalled by their manufacturer due to potential safety defects. Using a compromised syringe for a saline flush can introduce contaminants or result in sub-optimal medical treatment, posing a moderate risk to patients undergoing IV procedures.

What You Should Do

  1. Identify if you have the affected IV Start Kits by checking for REF number 74654 and UDI-DI 10809160020388 on the packaging.
  2. Check the package for the following specific lot numbers: 299477, 299849, 302983, 304173, 305500, 305501, 305514, 306363, 306683, 307030, 307809, 310701, 310887, 311741, 312807, or 313961.
  3. If you possess any kits from these affected lots, stop using them immediately and set them aside to prevent accidental use.
  4. Contact your healthcare provider or Medical Action Industries, Inc. 306 at their Arden, North Carolina facility for specific instructions on returning or replacing the kits.
  5. For further information or to report concerns, contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Manufacturer and Healthcare Consultation

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: IV Start Kit (100 kits/case)
Model / REF:
REF 74654
UDI-DI 10809160020388
Lot Numbers:
299477
299849
302983
304173
305500
305501
305514
306363
306683
307030
307809
310701
310887
311741
312807
313961

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94181
Status: Active
Manufacturer: Medical Action Industries, Inc. 306
Manufactured In: United States
Units Affected: 206,200 kits
Distributed To: Minnesota, North Dakota

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.