Baxter 因可能含玻璃纤维颗粒自愿召回一批枸橼酸钠抗凝溶液（批号 Y493475）
Baxter Issues Voluntary Nationwide Recall for One Lot of Anticoagulant Sodium Citrate Solution Due to Potential Presence of Particulate Matter
Baxter 于 2026 年 8 月 25 日宣布自愿召回一批枸橼酸钠抗凝溶液 USP，原因是溶液中可能含有被鉴定为玻璃纤维的颗粒物。涉及批号 Y493475，规格为 250 mL VIAFLEX 塑料容器，有效期 2027 年 12 月 31 日，该批次于 2026 年 7 月 2 日至 7 月 11 日分销给美国一名客户。
材料列出召回批次的产品代码、批号、有效期及美国一名客户的分销时间，便于核对受影响库存与退货范围。
COMPANY ANNOUNCEMENT
When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.
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Summary
- Company Announcement Date:
- August 25, 2026
- FDA Publish Date:
- August 25, 2026
- Product Type:
- Drugs
- Reason for Announcement:
-
Recall Reason Description
Potential presence of particulate matter identified as fiberglass in the solution
- Company Name:
- Baxter International Inc.
- Brand Name:
-
Brand Name(s)
Baxter
- Product Description:
-
Product Description
Anticoagulant Sodium Citrate Solution USP, 250 mL VIAFLEX Plastic Container
Company Announcement
FOR IMMEDIATE RELEASE – AUG. 25, 2026 – DEERFIELD, Ill., Baxter International Inc. (NYSE:BAX) is voluntarily recalling one lot of Anticoagulant Sodium Citrate Solution due to the potential presence of particulate matter identified as fiberglass in the solution.
Risk Statement: Anticoagulant Sodium Citrate Solution is intended for use with automated apheresis devices. Administration of Anticoagulant Sodium Citrate containing particulate matter may lead to adverse health consequences, the extent and severity of harm depend on the size, number, morphology and composition of the foreign material. In the absence of in-line filtration, these particles may cause local vein irritation, inflammatory or hypersensitivity reactions, and systemic embolization that could result in tissue or organ injury. As of 8/25/2026, Baxter has not received any reports of adverse events related to this issue.
The product is intended for use only with apheresis devices. It is not for direct intravenous infusion and the directions for use are contained in the owners operating and maintenance manual of the apheresis machine to be used. The product is packaged in 250 mL VIAFLEX Plastic Containers, with 36 units per case. Additional information can be found in the table below.
Affected Product:
Product | Product Description | Lot Number | Expiration Date | NDC Number |
|---|---|---|---|---|
2B7867Q | Anticoagulant Sodium Citrate | Y493475 | 31-Dec-2027 | 0338-9669-01 |
The affected lot can be identified by locating the lot number and expiration date on the individual product and shipping carton, as shown in the images below.
The impacted product was distributed from 7/2/2026 to 7/11/2026 to one customer in the United States.
The customer should immediately discontinue use of and return all affected units in accordance with their facility’s process. Baxter is contacting the customer by email with instructions on how to identify and return the impacted product.
For general questions regarding this communication, please contact Baxter Healthcare Center for Service at 888-229-0001 between the hours of 7:00 am and 6:00 pm Central Time, Monday through Friday.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm2 or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
The United States Food and Drug Administration (FDA) has been notified of this action.
Company Contact Information
- Consumers:
- Baxter Healthcare Center
- 888-229-0001
来源：FDA Drug Recalls · fda.gov