Baxter Says Packaging Change Caused Serious Recall

The Class I-level recall involves a peripheral vascular patch.

By Nancy Crotti

Baxter International, Inc. is voluntarily recalling four models of a peripheral vascular patch because a change in foil pouch packaging affected the patches' surface, possibly endangering patients.

FDA considers the recall a Class I, the most serious.

The Deerfield, IL, company reported 51 complaints involving the device to FDA, including postoperative thrombosis and stroke, according to an agency statement.

"Baxter is in the process of an in-depth investigation, and will share additional information as it becomes available," Baxter spokesman John O'Malley said via email to Qmed.

Surgeons use the Vascu-Guard patch to rebuild peripheral blood vessels such as the carotid in the neck and the renal in the kidneys. It is also used in arteriovenous access revisions.

Baxter is recalling the patch because it may be difficult for surgeons to distinguish the smooth side from the rough side of the implant, according to FDA. The packaging change caused the smooth surface of the patch to be too rough. If surgeons implant the rough side of the patch incorrectly (toward the bloodstream), blood clots may form on the patch, exposing patients to embolism, reduced blood flow, stroke, organ failure, or death, the agency said.

Patients who need repair of smaller arteries are at higher risk of blood clots forming within a blood vessel because blood flows more slowly through those vessels, FDA said. Patients whose blood disorders cause excessive clots to form may also be at a higher risk of forming clots on the surface of the device, the agency added. Baxter said in a statementthat "no causal association has been established" between the recalled products and adverse health events. The company is continuing to investigate.

Product codes are available on FDA's website.

Baxter began notifying all U.S. customers on May 2, 2015. Customers have been directed to locate and remove all affected product from their facilities. Recalled products should be returned to Baxter for credit by contacting Baxter Healthcare Center for Service at 1-888-229-0001, Monday through Friday, between the hours of 7:00 a.m. and 6:00 p.m., Central Time. Vascu-Guard patches packed in a plastic jar filled with sterile water and 1% propylene oxide are unaffected by this recall, the company said.

Nancy Crotti is a contributor to Qmed and MPMN.

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