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 8, 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 three import alerts for certain syringe products supplied by Jiangsu Shenli Medical Production Co. Ltd. and by Jiangsu Caina Medical Co. Ltd. These import alerts can be found at the following two webpages: ·
- https://www.accessdata.fda.gov/cms_ia/importalert_241.html
- https://www.accessdata.fda.gov/cms_ia/importalert_244.html
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 5, 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.
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. Additional information regarding this recall can be found on Sol-Millennium’s website.
McKesson Medical-Surgical is currently working with Sol-Millennium to confirm additional details regarding the recall, including the product disposition instructions for our customers. Additional information will be provided on this site as it becomes available.
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.
- Warning Letter: Jiangsu Shenli Medical Production Co., Ltd. - 677753 - 03/18/2024 | FDA
- Warning Letter: Sol-Millennium Medical, Inc. - 677524 - 03/18/2024 | FDA
- Warning Letter: Medline Industries, LP - 677545 - 03/18/2024 | FDA
- Warning Letter: Cardinal Health 200, LLC - 679404 - 04/24/2024 | FDA
Resources for Customer Questions or Concerns
- Questions about the updated Safety Communication can be sent by email to the Division of Industry and Consumer Education (DICE) at DICE@FDA.HHS.GOV (mailto:DICE@FDA.HHS.GOV) or call 800-638-2041 or 301-796-7100.
- To contact McKesson Medical-Surgical with product questions, please email MMSSyringe@McKesson.com.
- If you think you had a problem with a syringe, or any medical device, the FDA encourages you to report the problem through the MedWatch Voluntary Reporting Form: https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.home.
- FDA also advises that health care personnel employed by facilities that are subject to the FDA's user facility reporting requirements should follow the reporting procedures established by their facilities. If you are experiencing supply issues for syringes, or other devices, you may contact the FDA about a medical device supply chain issue at https://www.fda.gov/medical-devices/medical-device-supply-chain-and-shortages/notify-fda-about-medical-device-supply-issue. Reporting supply chain issues to the FDA helps inform actions to prevent shortages and protect patient health.
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.