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Lower risk Medical device recall · FDA · Published February 1, 2018

Medline 0:9% Sodium Chloride Injection Recall: Incorrect Overwrap Hazard

Medline recalls 0.9% Sodium Chloride Injection in 10mL syringes due to incorrect overwrap packaging. This may lead to improper use during IV procedures. Affected lots: 3131591.

🇺🇸 FDA recall #Z-2948-2018Medical deviceMedline ›
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Recalling firmMedline Industries IncThree Lakes Drive · Northfield, IL 60093
✎ GovInfoNow plain-language explainer

Medline is recalling 0.9% Sodium Chloride Injection in 10mL syringes because they were packaged with the wrong overwrap. This could cause improper use during IV procedures if the syringe is not handled correctly. Read more at govinfonow.com/recall/72057-medline-0-9-sodium-chloride-injection-recall-incorrect-overwrap-hazard.

Source Summary by GovInfoNow · govinfonow.com/recall/72057-medline-0-9-sodium-chloride-injection-recall-incorrect-overwrap-hazard · Updated August 31, 2026 · FDA enforcement record: FDA #Z-2948-2018

Cite this page

“Medline 0:9% Sodium Chloride Injection Recall: Incorrect Overwrap Hazard.” GovInfoNow, updated August 31, 2026. https://govinfonow.com/recall/72057-medline-0-9-sodium-chloride-injection-recall-incorrect-overwrap-hazard. Based on FDA recall #Z-2948-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2948-2018%22&limit=1).

The FDA announced on 2018-02-01 that Medline Industries Inc is recalling Medline 0.9% Sodium Chloride Injection, USP 5 mL in 10 mL Syringe ZR due to packaging with an incorrect overwrap. The recall affects 90,870 units distributed nationwide.

How to tell if you have it

  • Brand: Medline
  • Product: Medline 0.9 % Sodium Chloride Injection, USP 5 mL in 10 mL Syringe ZR
  • Lot #: 3131591

The hazard

The product was packaged with an incorrect overwrap, according to the FDA. The device is intended for flushing IV catheters and IV tubing only.

Context

GovInfoNow's records show Medline Industries Inc has 48 other recalls on record since 2015-09-25. Other recent recalls of similar products include Medline Chest Tube Kit Recalled (2022-07-21), Medline Hand Sanitizer Foam Recall (2021-11-08), and Medline Bedside PICC CDS Kit Recall (2021-10-27). Additional recent actions include Medline recalls of 10mL colored syringes, 10mL Polycarbonate Syringes, and Convenience Kits with Unapproved Syringes, all reported on 2026-02-27.

How to tell if you have this one

Check for the lot number 3131591 on the syringe packaging. The product is a 0.9% Sodium Chloride Injection in 10mL syringes intended for IV catheter flushing.

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

What to do — step by step

  1. Check Syringe Packaging

    Look for the lot number 3131591 on the syringe packaging to confirm if it is affected.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 27 states.

Alaska: nationwideAKMaine: nationwideMEVermont: named in the noticeVTNew Hampshire: nationwideNHWashington: named in the noticeWAIdaho: nationwideIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: named in the noticeMNIllinois: nationwideILWisconsin: nationwideWIMichigan: nationwideMINew York: named in the noticeNYRhode Island: named in the noticeRIMassachusetts: named in the noticeMAOregon: named in the noticeORNevada: nationwideNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: nationwideIAIndiana: named in the noticeINOhio: named in the noticeOHPennsylvania: named in the noticePANew Jersey: named in the noticeNJConnecticut: named in the noticeCTCalifornia: named in the noticeCAUtah: nationwideUTColorado: nationwideCONebraska: nationwideNEMissouri: nationwideMOKentucky: nationwideKYWest Virginia: named in the noticeWVVirginia: named in the noticeVAMaryland: named in the noticeMDDelaware: named in the noticeDEArizona: nationwideAZNew Mexico: named in the noticeNMKansas: nationwideKSArkansas: nationwideARTennessee: named in the noticeTNNorth Carolina: named in the noticeNCSouth Carolina: named in the noticeSCDistrict of Columbia: nationwideDCOklahoma: named in the noticeOKLouisiana: named in the noticeLAMississippi: named in the noticeMSAlabama: nationwideALGeorgia: named in the noticeGAHawaii: nationwideHITexas: named in the noticeTXFlorida: named in the noticeFL

FDA distribution: “US Nationwide Distribution to states of: CA, CT, DE, FL, GA, IN, LA, MA, MD, MN, MS, NC, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, VA, VT, WA and WV” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: California, Connecticut, Delaware, Florida, Georgia, Indiana, Louisiana, Maryland, Massachusetts, Minnesota, Mississippi, New Jersey, New Mexico, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Vermont, Virginia, Washington, West Virginia.

Recall timeline

FDA terminated this recall 2.7 years after the firm started it.

1. Firm started the recall: Feb 1, 201812. FDA classified it Class II: Aug 29, 201823. Published in FDA’s Enforcement Report: Sep 5, 201834. FDA terminated the recall: Oct 5, 2020420182020
  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 there a risk of injury from this product?

The hazard is related to incorrect overwrap packaging, which could lead to improper handling during IV procedures. However, the risk is low and does not involve immediate danger to users.

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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-2948-2018 (February 1, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2948-2018 to see it in context.
  • Plain-language summary written by qwen3:4b on August 31, 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