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Lower risk Medical device recall · FDA · Published August 2, 2021

Magnolia Medical Steripath Luer Transport Pack Gen2: Incorrect Instructions Risk

Magnolia Medical recalls Steripath Luer Transport Pack Gen2 due to incorrect transfer adapter instructions. This may lead to improper specimen handling. Affected units include specific catalog and lot numbers.

🇺🇸 FDA recall #Z-2393-2021Medical deviceMagnolia Medical ›
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Recalling firmMagnolia Medical Technologies, Inc.200 W Mercer St Ste 500 · Seattle, WA 98119-5908
✎ GovInfoNow plain-language explainer

What happened, in plain English

Magnolia Medical is recalling their Sterip:ipath Luer Transport Pack Gen2 because it came with the wrong instructions for use. This could cause improper handling of specimens during blood or urine collection. The recall affects specific catalog and lot numbers. Read more at govinfonow.com/recall/62105-magnolia-medical-steripath-luer-transport-pack-gen2-incorrect-instructions-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/62105-magnolia-medical-steripath-luer-transport-pack-gen2-incorrect-instructions-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2393-2021

Cite this page

“Magnolia Medical Steripath Luer Transport Pack Gen2: Incorrect Instructions Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62105-magnolia-medical-steripath-luer-transport-pack-gen2-incorrect-instructions-risk. Based on FDA recall #Z-2393-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2393-2021%22&limit=1).

Why it’s dangerous

The product was shipped with incorrect instructions for use, which could lead to improper handling of specimens. This might result in incorrect blood or urine collection procedures if the healthcare provider follows the wrong instructions.

Who’s affected

Healthcare professionals using the Steripath Luer Transport Pack Gen2 for specimen collection are most at risk. Patients receiving blood or urine samples through this device may also be affected.

How to tell if you have this one

Check for catalog number 27BD-EN and part number P00165-000 on the product. The lot number 9448037 is also associated with this recall.

  • Brand
    Magnolia Medical
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Instructions

    Review the product's instructions for use to ensure they match the correct transfer adapter procedures.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 16 states.

Alaska: nationwideAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: nationwideWAIdaho: nationwideIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: nationwideMNIllinois: named in the noticeILWisconsin: nationwideWIMichigan: named in the noticeMINew York: named in the noticeNYRhode Island: nationwideRIMassachusetts: nationwideMAOregon: nationwideORNevada: nationwideNVWyoming: named in the noticeWYSouth Dakota: nationwideSDIowa: nationwideIAIndiana: named in the noticeINOhio: nationwideOHPennsylvania: named in the noticePANew Jersey: nationwideNJConnecticut: nationwideCTCalifornia: nationwideCAUtah: nationwideUTColorado: named in the noticeCONebraska: named in the noticeNEMissouri: nationwideMOKentucky: nationwideKYWest Virginia: named in the noticeWVVirginia: named in the noticeVAMaryland: named in the noticeMDDelaware: nationwideDEArizona: nationwideAZNew Mexico: nationwideNMKansas: nationwideKSArkansas: nationwideARTennessee: nationwideTNNorth Carolina: nationwideNCSouth Carolina: named in the noticeSCDistrict of Columbia: nationwideDCOklahoma: nationwideOKLouisiana: nationwideLAMississippi: nationwideMSAlabama: named in the noticeALGeorgia: named in the noticeGAHawaii: nationwideHITexas: named in the noticeTXFlorida: named in the noticeFL

FDA distribution: “U.S. Nationwide distribution i the states of AL, CO, FL, GA, IL, IN, MD, MI, NE, NY, PA, SC, TX, VA, WV, and WY. O.U.S.: N/A” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, Colorado, Florida, Georgia, Illinois, Indiana, Maryland, Michigan, Nebraska, New York, Pennsylvania, South Carolina, Texas, Virginia, West Virginia, Wyoming.

Recall timeline

FDA terminated this recall 19 months after the firm started it.

1. Firm started the recall: Aug 2, 202112. FDA classified it Class II: Aug 31, 202123. Published in FDA’s Enforcement Report: Sep 8, 202134. FDA terminated the recall: Feb 22, 2023420212023
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. 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-2393-2021 (August 2, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2393-2021 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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA