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Lower risk Medical device recall · FDA · Published June 30, 2017

CareFusion VersaSafe 11-Gauge Cannula Recall: Packaging Punctures

CareFusion recalls VersaSafe 11-Gauge Cannula Model 9391-0200 due to punctures in blister packaging detected during manufacturing. This may cause injury during handling. Affected units have specific lot numbers.

🇺🇸 FDA recall #Z-3030-2017Medical deviceCareFusion ›
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Contact the company

Recalling firmCareFusion 303, Inc.10020 Pacific Mesa Blvd · San Diego, CA 92121-4386
✎ GovInfoNow plain-language explainer

What happened, in plain English

CareFusion is recalling VersaSafe 11-Gauge Plastic Cannulas (Model 9391-0200) because blister packaging has punctures that could lead to injury during handling. This recall affects specific lot numbers of the product used with IV sets or syringes. Read more at govinfonow.com/recall/73486-carefusion-versasafe-11-gauge-cannula-recall-packaging-punctures.

Source Summary by GovInfoNow · govinfonow.com/recall/73486-carefusion-versasafe-11-gauge-cannula-recall-packaging-punctures · Updated September 21, 2026 · FDA enforcement record: FDA #Z-3030-2017

Cite this page

“CareFusion VersaSafe 11-Gauge Cannula Recall: Packaging Punctures.” GovInfoNow, updated September 21, 2026. https://govinfonow.com/recall/73486-carefusion-versasafe-11-gauge-cannula-recall-packaging-punctures. Based on FDA recall #Z-3030-2017 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3030-2017%22&limit=1).

Why it’s dangerous

Punctures in the blister packaging can cause the product to be damaged or injured during handling. This may lead to minor injuries if the cannula is mishandled or if the packaging is compromised.

Who’s affected

Healthcare professionals and patients using the VersaSafe 11-Gauge Cannula with specific lot numbers for IV treatments or medication administration are affected. Those handling the product without proper precautions may face minor injury risks.

How to tell if you have this one

Check for the model number 9391-0200 on the product. Affected units have specific lot numbers listed in the recall notice: 1470303001, 1570314802, 1470303002, 1570317701, 1470304601, 1570317702, 1470306602, 1570317703, 1470306301, 1570317704, 1470306602, 1570322001, 1470311301, 1660771501, 1470306301, 1470311302, 1470314801.

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

What to do — step by step

  1. Check Product Lot Number

    Look for the lot numbers listed in the recall: 1470303001, 1570314802, 1470303002, 1570317701, 1470304601, 1570317702, 1470306602, 1570317703, 1470306301, 1570317704, 1470306602, 1570322001, 1470311301, 1660771501, 1470306301, 1470311302, 1470314801.

Where it went and when

Where it was distributed

Distributed in 8 states, and outside the U.S.

Alaska: not listedAKMaine: not listedMEVermont: not listedVTNew Hampshire: not listedNHWashington: not listedWAIdaho: not listedIDMontana: not listedMTNorth Dakota: not listedNDMinnesota: not listedMNIllinois: yesILWisconsin: not listedWIMichigan: yesMINew York: yesNYRhode Island: not listedRIMassachusetts: not listedMAOregon: not listedORNevada: not listedNVWyoming: not listedWYSouth Dakota: not listedSDIowa: not listedIAIndiana: yesINOhio: yesOHPennsylvania: not listedPANew Jersey: not listedNJConnecticut: not listedCTCalifornia: not listedCAUtah: not listedUTColorado: yesCONebraska: not listedNEMissouri: not listedMOKentucky: not listedKYWest Virginia: not listedWVVirginia: not listedVAMaryland: yesMDDelaware: not listedDEArizona: not listedAZNew Mexico: not listedNMKansas: not listedKSArkansas: not listedARTennessee: not listedTNNorth Carolina: not listedNCSouth Carolina: not listedSCDistrict of Columbia: not listedDCOklahoma: not listedOKLouisiana: not listedLAMississippi: not listedMSAlabama: not listedALGeorgia: not listedGAHawaii: not listedHITexas: yesTXFlorida: not listedFL

FDA distribution: “Worldwide Distribution in the states of : CO, IL, IN, MD, MI, NY, OH, & TX. and foreign countries of: Australia, New Zealand, & Japan.” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Colorado, Illinois, Indiana, Maryland, Michigan, New York, Ohio, Texas.

Recall timeline

FDA terminated this recall 3.6 years after the firm started it.

1. Firm started the recall: Jun 30, 201712. FDA classified it Class II: Aug 11, 201723. Published in FDA’s Enforcement Report: Aug 23, 201734. FDA terminated the recall: Feb 3, 2021420172021
  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.

✎ GovInfoNow

Questions people ask

Is this product dangerous to use?

The recall states punctures in the blister packaging were detected during manufacturing, but the product itself is not considered dangerous for use. The hazard is related to handling the packaging.

What should I do if I have this product?

Check the lot number on your product against the list provided in the recall notice. If it matches, contact CareFusion for further instructions.

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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-3030-2017 (June 30, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3030-2017 to see it in context.
  • Plain-language summary written by qwen3:4b on September 21, 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