BD recalls MEDLINE 111 Gravity Set with 3 Needle-Free Y-Sites (Catalog SAM2461) shipped as engineering sample labeled 'Not for Human Use' in the U.S. market.
Due to engineering sample labeled "Not for Human Use" being inadvertently shipped it the U.S. market.
BD is recalling a specific gravity set designed for medical use because it was mistakenly shipped to the U.S. as an engineering sample marked 'Not for Human Use'. This means the product should not be used on patients.
This gravity set was shipped to the U.S. as an engineering sample intended for internal testing, not for patient use. The label 'Not for Human Use' indicates it is unsafe for medical procedures.
Medical facilities that received this specific gravity set (Catalog SAM2461) in the U.S. market. Healthcare workers using the product for patient care are at risk if they use it incorrectly.
Check for the catalog number SAM2461 and reference DYNDTN0555 on the product. This gravity set was shipped to the U.S. market as an engineering sample labeled 'Not for Human Use'.
Look for the catalog number SAM2461 and reference DYNDTN0555 on the product.
This gravity set was shipped to the U.S. market as an engineering sample labeled 'Not for Human Use', meaning it was not intended for patient use.
No, this product is labeled 'Not for Human Use' and should not be used on patients.
The recall record does not specify a remedy, so contact BD directly for guidance.
We’ve drafted a message you can send BD to request your refund or repair — edit it as you like.
Subject: Recall Z-2654-2026 — BD BD Hello, I own a BD that is covered by recall Z-2654-2026 from BD. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
