AVID Medical, Inc. Halyard, CPT Basic IR Pack recall: Potential for open header bag seals, compromising sterility
Potential for open header bag seals, compromising sterility.
The hazard: Sterility or particulate concern
The concern here is contamination of a product that bypasses the body’s normal defences, which is why the threshold for recalling it is low.
What the notice says: Potential for open header bag seals, compromising sterility.
Why it matters: The product was made or packaged in conditions that cannot assure sterility, or visible particles were found in it. For anything injected, infused or used in the eye, that is a direct route for contamination into the body.
Symptoms and when to call a doctor
Watch for fever, chills, pain, redness, swelling or discharge at an injection site, and for a red, painful or suddenly blurred eye after using an eye product. Any of these needs same-day medical attention. Do not wait to see whether it settles, and tell the clinician which product and lot you used so it can be reported against the recall.
This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.
Recall details
- Recall number
- Z-2531-2025
- Published
- September 17, 2025
- Risk level
- Class II
- Status
- Ongoing
- Issued by
- U.S. Food and Drug Administration
- Brand
- AVID Medical, Inc.
- Product type
- Medical devices
- Units affected
- 228 units
- Distribution
- Nationwide
- Made in
- United States
- Lot / code info
- Model Number: 1646381. UDI: 10809160363256. Lot Number: 1646381. Expiration Date: 1/31/2028.
Products covered by this recall
Halyard, CPT BASIC IR PACK. Model Number: 1646381. Convenience kit.
Check your product
The notice names 2 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.
Best-by / use-by date
Printed beside the lot code, not on the price sticker.
- 31
- 2028. — 228 units
Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.
What to do about Sterility
AVID Medical, Inc. — The concern here is contamination of a product that bypasses the body’s normal defences, which is why the threshold for recalling it is low.
- Stop using the affected lot and check the lot number on your own carton or vial against the codes listed above.
- Do not use a vial or syringe with visible particles, cloudiness or discolouration, whether or not it is on the recall list.
- Call your prescriber or pharmacy today about a replacement from an unaffected lot — do not simply skip doses of a medicine you depend on.
- If you are a clinic or pharmacy, quarantine the stock and work it through your usual recall log.
Getting a replacement supply
Do not let a refund question interrupt your treatment. Deal with the supply first and the money second.
- Call the pharmacy before you run low. They can see which lot they dispensed to you and will usually swap it the same day.
- Insurers do not normally count a recall replacement against a refill limit. If one is refused, ask the pharmacist to call it through as a recall override.
- Over-the-counter products are refunded at the till like any other purchase; the recall notice on your phone is enough to explain the return.
- If the manufacturer runs a direct reimbursement form, it will be linked from the official notice on this page.
Company contact: AVID Medical, Inc. — 9000 Westmont Dr, Toano, VA, 23168-9351
The official notice
This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.
Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls
Questions people ask about this recall
Why was AVID Medical, Inc. medical devices recalled?
Potential for open header bag seals, compromising sterility. Potential for open header bag seals, compromising sterility.
How do I know if I have the recalled product?
Match the codes printed on your package against the notice: best-by date 31 or 2028. — 228 units. If the code on your package is not on that list, your unit is outside the recall.
What should I do with it right now?
Stop using the affected lot and check the lot number on your own carton or vial against the codes listed above.
Can I get my money back?
Call the pharmacy before you run low. They can see which lot they dispensed to you and will usually swap it the same day.
Where was the recalled product sold?
It was distributed nationwide.
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