Latest Updates from McKesson Medical-Surgical on Plastic Syringes Made in China Following FDA Warning Letters, Safety Communication, Import Alerts, and Product Recalls

Updated on June 11, 2024

McKesson Medical-Surgical is aware of the Warning Letters, issued on March 18, 2024 and April 24, 2024, by the U.S. Food and Drug Administration (FDA), and the FDA Safety Communication, most recently updated on May 23, 2024, related to quality and performance issues for certain plastic syringes made in China.

You can read the FDA Warning Letters on FDA’s website at www.fda.gov or by clicking the hyperlinks pasted below.

The updated FDA Safety Communication also includes important information and recommendations for consumers, health care providers and facilities and U.S. suppliers, including a recommendation to "immediately transition away” from using certain plastic syringes unless “absolutely necessary.” The updated Safety Communication can be found at the below link: 

FDA also announced four import alerts for certain syringe products supplied by:

  • Jiangsu Caina Medical Co. Ltd.
  • Jiangsu Shenli Medical Production Co. Ltd.
  • Shanghai Kindly Enterprise Development Group Co. Ltd.
  • Zhejiang Longde Pharmaceutical Co. Ltd.

These import alerts can be found at the following two webpages:

Supplier Actions

Cardinal Health

On March 28, 2024 and April 1, 2024, Cardinal Health 200, LLC. (Cardinal Health), which supplies certain plastic syringes distributed by McKesson Medical-Surgical, notified its customers that certain syringe and needle and syringe combination products were being placed on hold. On May 6, 2024, Cardinal Health notified its customers of an additional product hold on certain safety needles and blunt fill needles produced by Sol-Millennium Medical, Inc. As a result, we have placed all products specified in Cardinal Health’s customer notifications on hold. A list of impacted products can be found at the bottom of this webpage.

Medline Industries, LP

On April 8, Medline Industries, LP (Medline) initiated a voluntary recall of certain convenience kits containing syringes affected by FDA’s updated Safety Communication issued on March 19, 2024. As a result, we have placed all products specified in Medline’s recall notification on hold and notified customers who have ordered these products from us of the recall.

Subsequent Medline Industries, LP Actions Following Initial Voluntary Recall

Date
April 18, 2024

Supplier Name
Medline Industries, LP

Action Taken
Medline initiated a voluntary recall regarding certain convenience kits containing syringes.

 

June 3, 2024

Medline Industries, LP

FDA announced that Medline initiated a voluntary recall of certain plastic syringes.

 

We will continue to communicate additional measures taken by Medline Industries to our customers, including any corresponding action they need to take as appropriate.

Sol-Millennium Medical, Inc.

On May 8, Sol-Millennium Medical, Inc. (Sol-Millennium) initiated a voluntary recall of certain low dead space syringes, luer slip tip syringes, and combined syringes with needle and syringe components packaged together. Sol-Millennium’s recall action has been identified due to FDA’s determination that the specified devices require 510(k) clearance.

McKesson Medical-Surgical has notified its customers of the Sol-Millennium voluntary recall and has provided instructions to immediately discontinue using and to dispose of affected products. These communications include certain Sol-Millennium brand products and two McKesson Brands products (see item numbers 1150041 and 1150042 below) sourced from Sol-Millennium.

Subsequent Supplier Actions Following Sol-Millennium Recall

Date
May 22, 2024

Supplier Name
Busse Hospital Disposables

Action Taken
Busse Hospital Disposables recalled all of its convenience tray/kit containing affected Sol-Millennium syringes

 

We will continue to communicate additional actions taken by our other suppliers in response to the Sol-Millennium voluntary recall.

McKesson Medical-Surgical Actions

McKesson Medical-Surgical has stopped shipping the products specified in FDA’s Warning Letters issued on March 18, 2024. We continue to work with our suppliers to ensure that all appropriate actions have been taken with respect to the Warning Letters and subsequent product holds and recalls initiated by certain suppliers. This includes both privately labeled McKesson Brands and national brand products. McKesson Medical-Surgical is continuing to assess the situation, including the Warning Letter issued to Cardinal Health 200, LLC on April 24, 2024, to determine what, if any, additional action is required. Additional information can be found in the “Supplier Actions” section referenced above.

The McKesson Brands products identified in the March 18, 2024 Warning Letters include the following: 

  • Item number 1150041 Syringe/NDL, Safety Prevent HT3CC 25Gx1” (50/BX 8BX/CS)
  • Item number 1150042 Syringe/NDL, Safety Prevent HT3CC 25GX5/8” (50/BX 8BX/CS)
  • Item number 869662 Syringe/NDL, LL 60CC (25/BX4BX/CS)

Other national brand products identified in the March 18, 2024 and April 24, 2024 Warning Letters can be found referenced in the below links.

Resources for Customer Questions or Concerns

At McKesson Medical-Surgical, we are committed to patient safety and quality assurance. We continue to diligently work to source alternate sources for these products and diversify the manufacturers of the syringes we distribute. This includes manufacturers located in varied geographies.  We will provide further updates on this site, as appropriate.

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